Biomedical Device Regulatory Affairs Manager Job Vacancy in Nyagatare, Rwanda – Medical Technology & Regulatory Compliance

Job Description

Position: Biomedical Device Regulatory Affairs Manager

Company: Medtronic Rwanda

Location: Nyagatare, Rwanda

Experience: 5-8 years

Education: Master’s degree in Biomedical Engineering, Regulatory Affairs, Life Sciences, or related field

Employment Type: Full-time

Industry: Medical Technology & Regulatory Compliance

Department: Regulatory Affairs & Quality Assurance

Vacancies:1

Company Overview

Medtronic Rwanda is the regional subsidiary of Medtronic plc, a global leader in medical technology, services, and solutions. With operations spanning over 150 countries, Medtronic is dedicated to alleviating pain, restoring health, and extending life for millions of people worldwide. In Rwanda, we are committed to advancing healthcare through innovative medical devices and technologies, collaborating with healthcare providers, regulatory bodies, and communities to improve patient outcomes. Our presence in Nyagatare supports Rwanda’s vision for enhanced medical infrastructure and access to cutting-edge healthcare solutions. We foster a culture of integrity, inclusion, and collaboration, empowering our team to make a meaningful impact in the medical technology sector. As we expand our regulatory and compliance operations in East Africa, we seek passionate professionals to join our mission-driven organization.

Job Overview

We are seeking a highly skilled Biomedical Device Regulatory Affairs Manager to lead our regulatory compliance and submission strategies for medical devices in Rwanda and the broader East African region. This role is critical in ensuring that our innovative medical technologies meet all local and international regulatory requirements, facilitating timely market access and patient availability. The successful candidate will navigate complex regulatory landscapes, engage with the Rwanda Food and Drugs Authority (Rwanda FDA) and other regulatory bodies, and develop comprehensive regulatory pathways for new and existing products. This position offers a unique opportunity to shape the regulatory framework for advanced medical devices in a rapidly evolving healthcare market. If you are passionate about regulatory science and improving healthcare access, we encourage you to explore this career opportunity. For more Jobs in Rwanda and Career Opportunities in Rwanda, visit our partner site at https://rwandajobsearch.com.

Key Responsibilities

• Develop and execute regulatory strategies for the registration, licensing, and post-market surveillance of medical devices in Rwanda.
• Prepare, compile, and submit regulatory dossiers, including technical files, clinical evaluations, and quality management system documentation to the Rwanda FDA and other East African regulatory authorities.
• Serve as the primary regulatory liaison with the Rwanda FDA, Ministry of Health, and other relevant governmental and non-governmental organizations.
• Monitor and interpret evolving regulatory requirements, guidelines, and standards (e.g., ISO 13485, MDR, IVDR) impacting medical devices in the region.
• Lead regulatory intelligence activities to anticipate changes in the regulatory environment and advise internal stakeholders on compliance implications.
• Manage regulatory aspects of clinical investigations and ensure compliance with local ethical and regulatory standards.
• Coordinate with global regulatory teams to align regional strategies with corporate objectives and ensure consistency in regulatory submissions.
• Oversee the preparation and maintenance of regulatory documentation, including registrations, amendments, renewals, and variations.
• Provide regulatory guidance to cross-functional teams including R&D, Quality Assurance, Marketing, and Clinical Affairs throughout the product lifecycle.
• Conduct regulatory training for internal teams and external partners on compliance requirements and best practices.

Required Skills

• Expert knowledge of medical device regulations in Rwanda and familiarity with East African Community (EAC) and international regulatory frameworks.
• Proven experience in preparing and submitting successful regulatory dossiers for Class II and III medical devices.
• Strong project management skills with the ability to manage multiple regulatory projects and deadlines simultaneously.
• Excellent analytical and problem-solving abilities to navigate complex regulatory challenges.
• Outstanding communication and interpersonal skills for effective engagement with regulatory authorities and internal stakeholders.
• High attention to detail and commitment to regulatory compliance and quality.
• Ability to work independently and as part of a multidisciplinary team in a dynamic environment.
• Proficiency in regulatory software and document management systems.
• Fluency in English and Kinyarwanda; knowledge of French is an advantage.

Education

A Master’s degree in Biomedical Engineering, Regulatory Affairs, Life Sciences, Pharmacy, or a closely related field is required. Additional certifications such as RAC (Regulatory Affairs Certification) or similar international credentials are highly desirable. Continuous professional development in regulatory affairs and quality management systems is expected.

Experience

A minimum of 5-8 years of progressive experience in regulatory affairs within the medical device or pharmaceutical industry, with at least 3 years in a managerial or leadership role. Demonstrated experience in successful interactions with the Rwanda FDA or similar regulatory bodies in Sub-Saharan Africa is essential. Experience with product registration processes, clinical evaluation reports, and post-market surveillance is required.

Benefits

• Competitive salary package with performance-based incentives.
• Comprehensive health, dental, and vision insurance for employees and dependents.
• Retirement savings plan with company matching contributions.
• Generous paid time off, including vacation, sick leave, and public holidays.
• Professional development allowance for conferences, training, and certifications.
• Relocation assistance for eligible candidates moving to Nyagatare.
• Employee assistance program offering counseling and wellness resources.
• Opportunities for international travel and career advancement within a global organization.

Training

• Comprehensive onboarding program covering company policies, regulatory processes, and product portfolios.
• Specialized training in advanced regulatory submission strategies and electronic dossier management.
• Leadership and management development programs for career progression.
• Access to global Medtronic regulatory affairs networks and knowledge-sharing platforms.
• Regular workshops on updates in regional and international medical device regulations.

Working Environment

This role is based in our modern Nyagatare office, which features state-of-the-art facilities and a collaborative workspace designed to foster innovation and teamwork. We promote a hybrid working model, balancing office presence with remote flexibility. Our culture emphasizes ethical conduct, patient-centric innovation, and professional growth. You will work alongside a diverse team of experts in medical technology, contributing to life-changing healthcare solutions. We are committed to creating an inclusive environment where every team member can thrive and make a significant impact on healthcare in Rwanda.

Application Process

Interested candidates are invited to submit their updated CV and a cover letter detailing their regulatory experience and motivation for this role through our official careers portal. The application deadline is [Insert Date]. Shortlisted candidates will be contacted for initial virtual interviews, followed by assessments and final interviews with senior management. We appreciate all applications, but only those selected for further consideration will be contacted. For additional Job Vacancy in Rwanda listings and resources, please visit https://www.botswanajobsearch.com/.

Equal Opportunity Statement

Medtronic Rwanda is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment based on race, color, religion, sex, national origin, age, disability, or any other protected status under applicable law. We actively encourage applications from all qualified individuals, including women, persons with disabilities, and members of underrepresented groups. Our hiring decisions are based solely on qualifications, merit, and business needs. We are dedicated to providing Employment in Rwanda that fosters professional growth and contributes to the nation’s healthcare advancement.