Engineering

Biomedical Engineer

Taison Group·Nairobi, kenya·Full Time·Contract
EngineeringFull TimeContract
-Closes Nov 21, 2026
  • The Biomedical Engineer supports medical planning and equipment projects for new and refurbished healthcare facilities.
  • The role ensures that medical equipment (including imaging systems such as CT and X-ray) is correctly specified, assessed, planned, installed, commissioned and integrated into the built environment. The engineer collaborates closely with architects, clinical planners, construction teams, MEP engineers, clients and vendors to deliver safe, functional, regulatory-compliant healthcare infrastructure that meets clinical needs and project timelines.
  • Key Responsibilities

Medical Planning & Design Support

  • Participate in early-stage medical planning for healthcare projects, translating clinical requirements into spatial, technical, and infrastructure specifications.
  • Advise on room layouts, workflow, equipment placement, and adjacency requirements for diagnostic, treatment, and support areas (radiology, theatres, ICU, laboratories, etc.).
  • Review architectural, structural, and MEP drawings to ensure compatibility with medical equipment needs (power, HVAC, shielding, medical gases, data, load-bearing, infection control).
  • Contribute to functional design briefs, room data sheets, and equipment schedules.

Equipment Assessment, Selection & Procurement Support

  • Conduct needs assessments and technology evaluations for medical equipment (imaging, life-support, monitoring, laboratory, surgical, etc.).
  • Prepare technical specifications, evaluate vendor proposals and support tender/procurement processes.
  • Assess equipment for clinical suitability, total cost of ownership, interoperability, serviceability and compliance with Kenyan and international standards.
  • Provide input on lifecycle costing, maintenance contracts, and spare-parts strategies.

Project Management of Equipment Installations

  • Plan, coordinate and oversee installation, commissioning and handover of medical equipment, with particular emphasis on complex systems such as CT scanners, X-ray (fixed and mobile), ultrasound and related imaging suites.
  • Develop and manage installation programmes, method statements, risk assessments, and site readiness checklists.
  • Coordinate with construction teams, vendors, radiation protection officers, and facility managers to ensure seamless integration (shielding, power, cooling, structural modifications, radiation safety).
  • Supervise site works related to equipment foundations, cabling, medical gas connections, and associated MEP works.
  • Manage interfaces between equipment suppliers, contractors, and clinical end-users; resolve technical queries and non-conformances promptly.

Installation, Commissioning, Maintenance & Technical Support

  • Oversee or perform installation, calibration, acceptance testing and commissioning of biomedical equipment.
  • Develop and implement preventive maintenance programmes and schedules.
  • Troubleshoot technical issues during and after installation; coordinate warranty and post-warranty service.
  • Maintain accurate equipment inventories, asset registers, service histories, and documentation.
  • Support training of clinical and technical staff on safe and effective equipment use.

Compliance, Quality & Safety

  • Ensure all equipment and installations comply with relevant standards (Kenya Bureau of Standards, Pharmacy and Poisons Board / medical device regulations, radiation safety, IPC/ICRA for construction in healthcare settings, manufacturer guidelines, and international best practice such as IEC/ISO where applicable).
  • Conduct risk assessments, failure mode analyses, and incident investigations related to medical devices.
  • Support radiation protection planning and verification for imaging rooms.
  • Maintain rigorous documentation for audits, handover, and regulatory submissions.

Collaboration & Continuous Improvement

  • Work closely with multidisciplinary project teams (architects, quantity surveyors, site engineers, clinical planners, clients).
  • Provide technical input during design reviews, value engineering, and change management.
  • Stay current with advances in medical technology, regulatory changes, and healthcare construction best practices; recommend improvements.
  • Mentor junior staff or technicians as required and contribute to knowledge sharing within the Group.
  • Key Performance Indicators / Measures & Expectations
  • On-time delivery of equipment planning, installation, and commissioning milestones (target ≥ 90 - 95% of planned dates met).
  • Quality & compliance - zero major non-conformances or regulatory findings related to equipment installations; successful first-time acceptance testing and handover.
  • Cost control - equipment and installation packages delivered within approved budgets; effective contribution to value engineering without compromising clinical or safety standards.
  • Technical accuracy - completeness and accuracy of equipment specifications, schedules, and technical documentation; low rate of post-installation design changes attributable to biomedical input.
  • Stakeholder satisfaction - positive feedback from project managers, clients, clinical users, and vendors on responsiveness, technical competence, and collaboration.
  • Safety & risk management - timely completion of risk assessments, method statements, and radiation/IPC-related requirements; no serious safety incidents linked to equipment works.
  • Documentation & knowledge - up-to-date equipment registers, service records, and lessons-learned contributions for future projects.
  • Professional development - maintenance of current knowledge of relevant technologies and regulations; contribution to team capability building.
  • Qualifications
  • Bachelor's degree in Biomedical Engineering (or closely related field such as Medical Engineering / Clinical Engineering). A Master's degree is an advantage.
  • Proven experience in medical planning, equipment assessment/selection, and project management of medical equipment installations, ideally including CT / X-ray (or other major imaging modalities).
  • Hands-on experience with installation, commissioning, or technical management of diagnostic imaging and other critical care / hospital equipment in healthcare construction or hospital settings.
  • Strong understanding of hospital infrastructure requirements (medical gases, HVAC for clinical areas, electrical systems, radiation shielding, IPC).
  • Ability to read and interpret architectural, structural, and MEP drawings and technical equipment manuals.
  • Project management skills: planning, coordination, risk management, and delivery against programme and budget.
  • Knowledge of relevant Kenyan regulations and international standards for medical devices and healthcare facilities.
  • Excellent communication, stakeholder management, and report-writing skills.
  • Proficiency with Microsoft Office / project tools; familiarity with CAD or BIM viewing is an advantage.
  • Willingness to travel to project sites across Kenya and work flexible hours as project demands require.
  • Professional registration or membership with a relevant engineering body (e.g., Engineers Board of Kenya) is desirable.

Working Conditions

  • Primarily office-based in Nairobi with regular site visits to active construction and healthcare projects. Occasional extended hours or weekend work may be required to meet critical installation or commissioning windows. Personal protective equipment and site safety compliance are mandatory.
  • This role is ideal for a proactive Biomedical Engineer who thrives at the intersection of clinical needs, engineering, and construction delivery, and who is motivated to help build high-quality healthcare infrastructure across Kenya.

Key skills

BA/BSc/HNDMBA/MSc/MA

At a glance

Company

Taison Group

Location

Nairobi, kenya

Employment

Full Time

Experience

Valid until

November 21, 2026

Created

October 22, 2026

More opportunities

Similar roles you might like

Sales Representatives

CDL Human Resource

Nairobi, kenya

full-time

Job Summary We are seeking two proactive, results-driven, and customer-focused Sales Representatives / Territory Developers to drive sales growth and expand our market presence through the development of new business accounts and the management of existing customers. The successful candidates will be responsible for identifying, prospecting, and developing business opportunities across pharmacies, hospitals, physiotherapy clinics, rehabilitation centres, and other relevant healthcare institutions. The role requires individuals with proven experience in medical equipment, medical devices, pharmaceutical products, or other healthcare-related product sales, with a strong ability to build professional relationships, demonstrate products, negotiate sales, and convert leads into long-term customers. The ideal candidates should have a strong commercial mindset, excellent communication and negotiation skills, and a proven track record of acquiring new accounts and achieving sales targets. They should be comfortable conducting field visits, delivering product demonstrations, coordinating product activations, following up on orders and payments, and maintaining accurate customer and sales records. Candidates with a background in physiotherapy, clinical practice, rehabilitation, or medical equipment sales will have a distinct advantage. Key Responsibilities Business Development and New Account Acquisition Identify, prospect, and develop new business opportunities within assigned territories. Establish and grow relationships with pharmacies, hospitals, physiotherapy clinics, rehabilitation centres, medical practices, and other relevant healthcare providers. Proactively identify decision-makers, including hospital administrators, procurement officers, pharmacists, physiotherapists, clinicians, and business owners. Conduct cold calls, field prospecting, scheduled visits, referrals, and other business development activities to generate qualified leads. Present the company's products and value proposition to prospective customers and convert prospects into active accounts. Develop and implement territory-specific sales plans to achieve customer acquisition, revenue, and market penetration targets. Maintain a healthy pipeline of prospective customers and consistently follow up on leads until conversion. Identify opportunities to introduce new products to existing customers and expand account value. Monitor competitor activities, pricing, customer preferences, and market trends to identify opportunities for business growth. Medical Equipment and Healthcare Product Sales Promote and sell medical equipment, rehabilitation products, physiotherapy equipment, medical devices, and other assigned healthcare products. Understand product features, specifications, benefits, applications, and competitive advantages to communicate value effectively to customers. Assess customer requirements and recommend appropriate products based on their operational, clinical, or business needs. Conduct professional product presentations and demonstrations for healthcare professionals, procurement teams, and other relevant stakeholders. Explain product usage, functionality, maintenance requirements, and relevant safety considerations within the scope of product training and authorization. Coordinate product trials, demonstrations, and evaluations where applicable. Work with technical, clinical, or service teams to address product-related questions and support customer requirements. Ensure that all product information and sales representations are accurate and consistent with approved product claims and applicable requirements. Account Management and Customer Relationship Development Build and maintain strong, long-term relationships with existing customers to encourage repeat business and customer loyalty. Conduct regular customer visits to assess satisfaction, identify additional needs, and generate repeat orders. Maintain an up-to-date database of customer contacts, purchasing patterns, product preferences, and business opportunities. Identify cross-selling and upselling opportunities across the company's product portfolio. Respond promptly to customer enquiries, complaints, and requests for quotations or product information. Coordinate with internal teams to ensure timely order processing, delivery, installation, training, or after-sales support, where applicable. Maintain regular communication with key accounts and develop account plans for high-potential customers. Product Demonstrations, Activations, and Market Development Plan and execute product demonstrations, promotional campaigns, customer education sessions, and product activations. Organize demonstrations at hospitals, pharmacies, physiotherapy clinics, rehabilitation centres, and other relevant facilities. Support product launches, trade exhibitions, healthcare events, professional forums, and other marketing initiatives. Identify suitable opportunities to increase product visibility and awareness among healthcare professionals and institutional buyers. Gather customer feedback during demonstrations and activations and communicate insights to the sales and marketing teams. Track leads generated from activations and ensure timely follow-up and conversion into sales. Sales Target Achievement and Territory Management Work towards achieving monthly, quarterly, and annual sales targets. Develop and maintain an effective territory coverage plan, ensuring consistent engagement with existing and prospective accounts. Prioritize high-potential customers and sales opportunities to maximize revenue and territory growth. Prepare sales forecasts and provide regular updates on pipeline value, expected orders, and potential challenges. Monitor sales performance against targets and take corrective action where necessary. Identify opportunities to improve market share, customer coverage, product penetration, and revenue generation within the assigned territory. Order Processing, Collections, and Payment Follow-Up Prepare and submit quotations, proposals, order requests, and other sales documentation in accordance with company procedures. Follow up on customer orders to support timely processing, fulfilment, and delivery. Coordinate with finance, stores, logistics, and other relevant departments to resolve order-related issues. Monitor outstanding customer invoices and proactively follow up on payments in line with agreed credit terms and company policies. Support the collection of overdue accounts and promptly escalate payment delays or credit concerns. Maintain accurate records of orders, invoices, customer commitments, and collection follow-ups. Balance sales growth with responsible credit management and customer relationship preservation. CRM Management, Reporting, and Administration Record all customer visits, calls, meetings, demonstrations, leads, opportunities, and follow-up actions in the company's CRM system. Maintain accurate and up-to-date customer and prospect information. Submit weekly sales reports covering customer visits, new leads, accounts opened, sales achieved, pending orders, collections, and pipeline opportunities. Prepare regular territory performance updates, sales forecasts, and competitor intelligence reports. Maintain a clear schedule of planned customer visits and ensure that follow-up commitments are completed on time. Ensure sales activities and documentation comply with company policies and reporting requirements. Provide accurate information to management to support sales planning, forecasting, and decision-making. Qualifications and Experience Minimum Requirements A diploma or degree in Sales and Marketing, Business Administration, Medical Sales, Biomedical Engineering, Clinical Medicine, Physiotherapy, Pharmacy, or another relevant field. At least two (2) years of demonstrable experience in medical equipment, medical devices, pharmaceutical products, healthcare supplies, or related B2B sales. A proven track record of acquiring new customers and converting prospects into active revenue-generating accounts. Demonstrated experience selling medical equipment or healthcare products to hospitals, pharmacies, clinics, rehabilitation centres, or other institutional customers. A valid driving licence and willingness to travel regularly within the assigned territory. Strong communication, presentation, negotiation, and relationship-management skills. Proficiency in Microsoft Office and the ability to maintain accurate CRM records and sales reports. Ability to work independently, manage a field-sales schedule, and consistently meet sales targets. Preferred Qualifications and Experience Previous experience selling physiotherapy, rehabilitation, orthopaedic, diagnostic, hospital, or other medical equipment. A background in physiotherapy, clinical practice, biomedical technology, rehabilitation, or another healthcare-related discipline. Existing professional relationships with healthcare providers, procurement teams, hospital administrators, pharmacists, or physiotherapy practitioners. Experience conducting product demonstrations, equipment trials, clinical product presentations, or healthcare-sector activations. Experience managing institutional accounts, negotiating commercial terms, and following up on customer collections. Familiarity with CRM platforms, sales pipeline management, and territory planning.

3 days ago

Nurse In Charge

City Eye Hospital

Nairobi, kenya

full-time

Overall Purpose of the Role To lead the daily patient-care and operational delivery of the Appointment Clinic, ensuring approved services are safely staffed, ready on time, and delivered through a well-coordinated patient journey. The role is responsible for nursing standards, clinic readiness, patient flow, accurate reporting, and achievement of agreed revenue, conversion, and utilisation targets within approved clinical capacity. Main Duties and Responsibilities Technical Skills Revenue Conversion & Utilisation Performance Monitor performance against approved Appointment Clinic revenue targets, explain significant operational variances, and implement or escalate corrective actions. Track appointment attendance, completion of clinically advised services, eligible same-day service completion, referrals to Main Hospital, and utilisation of confirmed clinic and diagnostic capacity. Maintain an accurate register of recommended investigations, procedures, surgeries, and transfers, including authorisation, booking, follow-up actions, and completion status. Review pending and overdue cases weekly, assign next actions, and coordinate follow-up, pre-authorisation, and handover to Main Hospital or other approved service points. Provide Finance with complete activity and transfer records to support validation of Appointment Clinic and agreed Appointment Clinic-originated revenue. Ensure commercial targets never compromise clinical judgement, appropriate care, or patient choice. Clinic Readiness, Capacity & Patient Flow Maintain a rolling eight-week clinic schedule in collaboration with the Head of Patient Services and Medical Director, covering approved capacity, clinician availability, bookable slots, staffing, and required mitigation measures. Lead daily readiness meetings covering staff schedules, bookings, equipment, consumables, transfers, and anticipated delays. Allocate nurses and ophthalmic assistants for regular, dual-clinician, specialist, and Saturday sessions, including staff leave and transfers to Main Hospital. Record and promptly escalate uncovered sessions, clinician delays, cancellations, and capacity constraints. Coordinate approved patient communication, rescheduling, and alternative care pathways where necessary. Oversee patient flow from reception through assessment, consultation, diagnostics, procedures, payment, discharge, and follow-up. Monitor waiting times by clinic and implement approved workflow improvements to reduce avoidable delays. Patient Access & Experience Ensure booked patients receive appointment confirmations and reminders through the agreed process. Coordinate with the Appointment Clinic front-office team to record and follow up on cancellations and missed appointments. Keep patients informed about delays and next steps, address complaints promptly, and escalate unresolved service issues. Monitor patient movement after arrival and coordinate workflow changes where bottlenecks are identified. Clinical Governance, Patient Safety & Nursing Care Ensure nursing care complies with approved clinical protocols, infection-prevention standards, medication controls, emergency procedures, and professional scope of practice. Supervise triage, patient preparation, and pre-procedure and post-procedure nursing care. Ensure emergency equipment, supplies, and assigned staff are ready for patient care. Record and escalate incidents, near misses, unsafe conditions, and repeated scheduling deviations through approved governance channels. Follow up on assigned corrective actions until completion. Support clinical audits and quality-improvement initiatives. Ensure changes to clinical protocols or decisions outside nursing scope receive approval from the Medical Director or designated clinical lead. Equipment, Inventory & Operational Controls Coordinate the availability and appropriate use of diagnostic equipment. Work with Biomedical Engineering to report equipment faults and follow up on downtime and repairs. Maintain adequate stocks of drugs, consumables, and critical supplies. Oversee ordering, storage, dispensing, and movement of supplies in accordance with organisational policies. Coordinate monthly stock counts and report material variances, wastage, breakages, expired items, and unexplained usage. Protect the confidentiality, completeness, and proper custody of patient, staff, equipment, and operational records. Data Reporting & Performance Improvement Maintain a consolidated Appointment Clinic performance tracker, ensuring patient totals reconcile with booking, attendance, source, and service records. Keep unresolved data discrepancies visible and escalate them rather than estimating figures. Prepare and submit agreed weekly performance scorecards and accurate monthly operational reports covering clinic capacity, attendance, waiting times, patient sources, completed services, transfers, pending patient journeys, and significant operational exceptions. Work with Cashiers, Front Office, and Main Hospital service leads to reconcile operational records and resolve or disclose discrepancies. Use performance data to recommend improvements in workflow, staffing, capacity, and service delivery. Follow approved improvement actions through to verified completion. People Management & Leadership Lead, coach, and supervise nurses and ophthalmic assistants assigned to the Appointment Clinic. Allocate duties, manage attendance and leave, conduct performance reviews, and address conduct or capability concerns through approved HR procedures. Exercise day-to-day functional authority over front-office, cashier, and support staff deployed at the clinic in matters relating to readiness, patient flow, safety, and service continuity, while respecting their established reporting lines. Provide the Commercial team with verified service information, clinic dates, and bookable capacity to support patient acquisition activities. Identify and escalate staffing, equipment, infrastructure, and system requirements using evidence of workload, patient volumes, risk, and service opportunities. Key Accountabilities & Performance Areas Performance will be assessed across the following areas: Operational Readiness & Capacity - 20%:Clinic scheduling, staffing readiness, service availability, and timely management or escalation of uncovered sessions. Patient Flow & Experience - 15%: Waiting times, communication during delays, complaint handling, and patient experience. Revenue Conversion & Utilisation - 20%: Finance-validated revenue against targets, appointment attendance, completion of clinically advised services, eligible same-day completion, referral completion, and capacity utilisation. Clinical Quality & Safety - 20%: Compliance with nursing and safety standards, timely escalation of significant risks, and completion of assigned corrective actions. Data Integrity & Reporting - 10%: Accurate, timely weekly and monthly reporting and reconciliation of source records. People Leadership - 10%: Staff deployment, attendance management, performance reviews, training, and completion of agreed team actions. Equipment, Inventory & Cost Control - 5%: Equipment availability, stock control, equipment fault follow-up, and explanation of significant variances. Knowledge, Experience & Qualifications Required Diploma or degree in Nursing from a recognised institution. Current Nursing Council of Kenya practising licence. Higher Diploma in Ophthalmic Nursing is strongly preferred. Candidates with substantial ophthalmic, ambulatory, or specialist-clinic experience and demonstrated leadership capability may also be considered. At least five years of nursing experience, including at least three years in ophthalmic, outpatient, or specialist-clinic care. Demonstrated experience supervising a clinic or patient-care team. Working knowledge of patient flow, clinical scheduling, pre-authorisation, diagnostic and procedure pathways, infection prevention, medication control, and patient-safety reporting. Ability to use Microsoft Excel or comparable reporting tools and interpret operational data relating to activity, waiting times, service completion, utilisation, staffing, and inventory. Behavioural Competencies Operational Ownership: Anticipates gaps, acts within authority, escalates issues early, and follows actions through to verified completion. Patient-Centred Judgement: Protects patient safety, dignity, access, and continuity of care while balancing demand with available capacity. Data Discipline: Uses source records, reconciles figures, and keeps unresolved data gaps visible. Leadership & Accountability: Sets clear expectations, addresses underperformance fairly, and maintains professional boundaries. Cross-Functional Coordination: Secures cooperation across departments while respecting each function's authority and accountability. Commercial Awareness: Understands how capacity, service completion, utilisation, cost, and patient experience contribute to sustainable growth without compromising patient care. City Eye Hospital Values: Demonstrates integrity, compassion, stewardship, and high standards, reflecting the values of honouring God, valuing people, and pursuing excellence.

6 days ago

Mms Sub-saharan Africa (ssa) Business Development Manager

Becton, Dickinson and Company (BD)

Nairobi, kenya

full-time

About the role The Business Development Manager will accelerate the growth of our Medication Management Solutions (MMS) business across East Africa. This is a strategic, hunter-focused role responsible for identifying and converting new business opportunities, building high-value customer relationships, and expanding adoption of our Infusion portfolio across Critical Care and Oncology. Working closely with distributors, healthcare providers, government stakeholders, and key decision-makers, you will drive market expansion, strengthen strategic accounts, and position BD as a trusted partner in advancing safer, smarter healthcare solutions. You will play a critical role in shaping our regional growth strategy, developing a sustainable opportunity pipeline, and supporting future expansion across Sub-Saharan Africa. Key Responsibilities Drive new business acquisition and accelerate market growth across East Africa. Identify, develop, and convert strategic opportunities within public and private healthcare sectors. Build and maintain strong relationships with distributors, healthcare providers, government stakeholders, procurement bodies, and key opinion leaders. Develop and execute regional growth plans and strategic account strategies aligned to business objectives. Lead complex commercial discussions, tenders, negotiations, and partnership agreements. Strengthen distributor performance through business planning, capability development, and joint customer engagement. Collaborate with clinical, marketing, technical, and commercial teams to support customer adoption and successful implementation of BD solutions. Maintain a robust opportunity pipeline, provide accurate forecasting, and deliver market intelligence to support future growth initiatives. Represent BD at industry events, customer meetings, and professional forums across the region. About You Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Healthcare, Business, or a related field. 5+ years of experience in business development, commercial sales, or strategic account management within the medical device, pharmaceutical, diagnostics, or healthcare industry. Proven track record of winning new business, driving revenue growth, and developing strategic customer relationships. Experience working with healthcare institutions, distributors, procurement bodies, and key stakeholders across Africa. Strong commercial acumen with the ability to manage complex sales cycles, tenders, and negotiations. Demonstrated success in market development, territory expansion, and opportunity pipeline management. Excellent stakeholder engagement, communication, and influencing skills. Self-motivated, entrepreneurial, and comfortable working independently in a fast-paced, matrix environment. Fluent in English and willing to travel extensively across the region.

20 days ago

Surgical Innovation Sales Manager – Indirect Africa

Medtronic

Kenya, kenya

Full-Time

Medtronic (www.medtronic.com), is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic’s mission is: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pa Surgical Innovation Sales Manager – Indirect Africa Responsibilities may include the following and other duties may be assigned: Own the regional commercial strategy and AOP delivery for SI, ACM and Endoscopy, translating business priorities into clear country, portfolio and distributor action plans Lead, coach and develop the field team across Indirect Africa, setting performance expectations, strengthening commercial capability and ensuring consistent execution across markets Govern distributor performance through structured business reviews, forecasting, pipeline management, inventory planning, pricing discipline and agreed corrective actions Prioritise growth opportunities across Core Surgical, Endoscopy, Patient Monitoring and Respiratory Interventions, ensuring resources are focused on the markets, customers and therapies with the highest potential Build strong relationships with key customers, clinical leaders, distributors and internal stakeholders to support therapy adoption, education plans, tenders and strategic partnerships Partner with marketing, market development, finance, supply chain, regulatory, clinical, legal and compliance teams to support new product introductions and reliable market execution Maintain high standards of ethics, compliance, data quality and operating discipline while providing accurate forecasts, business insights and updates to leadership Required Knowledge and Experience: Bachelor’s degree in business, life sciences, engineering, healthcare or a related discipline Meaningful commercial experience in medical devices, healthcare or a comparable regulated industry, including responsibility for sales delivery across multiple markets Proven experience leading people and/or complex distributor networks, with the ability to coach teams and influence partners across different cultures and geographies Strong capability in business planning, forecasting, pipeline management, tender execution, pricing and financial performance management Fluent business English plus Arabic and/or French as a mandatory language requirement Ability and willingness to travel frequently across Indirect Africa, with a strong commitment to ethical conduct, compliance and inclusive leadership Preferred Qualifications: Experience across Surgical Innovations, Acute Care & Monitoring, Endoscopy or related portfolios, together with knowledge of distributor-led African markets, would be an advantage. An MBA or relevant postgraduate qualification is also desirable but not essential. Don't Keep Share!: WhatsApp Tweet

a month ago

Regulatory Affairs Specialist Africa

Terumo BCT

Nairobi, kenya

full-time

JOB SUMMARY The Regulatory Affairs Specialist is responsible for developing and executing regulatory strategies to obtain and maintain medical device registrations across African markets. The role supports business growth by ensuring compliance with applicable regulatory requirements and facilitating timely market access for medical devices throughout the African continent. The specialist serves as the primary regulatory contact for submissions, renewals, variations, and post-registration activities with national regulatory authorities and local representatives. The position requires a strong understanding of African medical device regulations, regional harmonization initiatives, quality management systems, and international regulatory standards. ESSENTIAL DUTIES AND RESPONSIBILITIES Regulatory Strategy and Submissions: Prepare, compile, review, and submit medical device registration dossiers to health authorities across Africa. Develop regulatory submission strategies to support product launches and business objectives. Coordinate new registrations, renewals, amendments, change notifications, and license maintenance activities. Manage regulatory timelines and ensure timely approvals and renewals. Support commercialization efforts by providing regulatory guidance for new product introductions. Compliance and Documentation: Maintain up-to-date knowledge of global regulatory requirements and ensure company practices align with these standards. Ensure proper documentation and maintenance of regulatory files and records. Authority and Distributor Management: Act as the primary contact with regulatory authorities, notified entities, local representatives, and distributors. Coordinate responses to authority questions, deficiency letters, and requests for additional information. Support distributor qualification and regulatory oversight activities. Facilitate interactions during inspections, audits, and authority meetings. Regulatory Intelligence: Stay informed of changes in the regulatory landscape and communicate potential impacts to senior management and other stakeholders. Participate in industry forums, conferences, and working groups to represent the company and gain insights into emerging regulatory trends. Provides key guidance on regulatory topics to cross functional MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or related scientific discipline. Advanced degree or Regulatory Affairs certification is an advantage. Experience 3 to 7 years of regulatory affairs experience within the medical device industry. Demonstrated experience managing medical device registrations in multiple African markets. Experience with Class I, II, III, and/or IV medical devices preferred. Experience working with distributors and local regulatory representatives. In depth knowledge of African medical device regulatory frameworks. Working knowledge of and ability to prepare regulatory documentation. Knowledge of: ISO 13485 ISO 14971 MDR/IVDR principles Global Medical Device Nomenclature (GMDN) IMDRF guidance documents Medical device technical documentation requirements Experience dealing with notified bodies and competent authorities Proven track record in managing MDR submissions and handling communications with external authorities (CA and notified body) Technical documentation management Ability to perform change assessment for changes impacting EMEA countries Skills In line with Terumo's Core Values: Demonstrated and effective leadership and team skills. Demonstrated ability to define problems and work with management to develop and implement solutions. A high level of initiative as well as willingness to take ownership and accept responsibility for actions and decisions. Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence. Demonstrated analytical and creative thinking skills and the ability to solve complex problems. Demonstrated ability to communicate effectively both verbally and in writing. Demonstrated interpersonal skills and the ability to represent the business in contacts with those both internal and external to the organization. Exhibits commitment to organizational goals and guiding principles. ADDITIONAL INFORMATION Please note that employment is offered on a contractor basis only (min. 6 months) Based: Kenya Reporting to: Regulatory Affairs Director- EMEA

a month ago