Regulatory Affairs Specialist Africa

About the role

Terumo is hiring a Regulatory Affairs Specialist (Job Band 9) based in Kenya, reporting to the Regulatory Affairs Director-EMEA. The specialist develops and executes regulatory strategies to obtain and maintain medical device registrations across African markets, ensures compliance with applicable requirements and facilitates timely market access. The role acts as the primary regulatory contact for submissions, renewals, variations and post-registration activities with national regulatory authorities and local representatives.

Key responsibilities

• Prepare, compile, review and submit medical device registration dossiers to health authorities across Africa, and coordinate new registrations, renewals, amendments, change notifications and license maintenance
• Develop regulatory submission strategies to support product launches and provide regulatory guidance for new product introductions
• Maintain regulatory files and records and keep up to date with global regulatory requirements
• Act as primary contact with regulatory authorities, notified entities, local representatives and distributors, including coordinating responses to deficiency letters and requests for additional information
• Support distributor qualification and regulatory oversight, and facilitate interactions during inspections, audits and authority meetings
• Monitor regulatory changes and communicate their impact to management, and share insights gained from industry forums and conferences

Required profile

• Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs or a related scientific discipline; advanced degree or Regulatory Affairs certification is an advantage
• 3 to 7 years of regulatory affairs experience in the medical device industry
• Demonstrated experience managing medical device registrations in multiple African markets, preferably with Class I, II, III and/or IV devices
• Experience working with distributors and local regulatory representatives
• Proven track record managing MDR submissions and communicating with external authorities and notified bodies

Required skills

• In-depth knowledge of African medical device regulatory frameworks and ability to prepare regulatory documentation
• Knowledge of ISO 13485, ISO 14971, MDR/IVDR principles, GMDN and IMDRF guidance
• Technical documentation management and ability to perform change assessments for changes affecting EMEA countries
• Leadership, communication and problem-solving skills aligned with the company's core values

Employment is offered on a contractor basis only (minimum 6 months).