Regulatory Affairs Manager – Medical Devices

About the role

We are looking for an experienced Regulatory Affairs Manager specialized in medical devices to join our talent network. This role will support upcoming client projects in device registration, market access, and ongoing compliance. The position may evolve into a project‑based, part‑time, contract, or full‑time engagement depending on business needs.

Key responsibilities

• Manage medical device registrations and regulatory submissions.
• Develop regulatory strategies to support product registration and market access.
• Provide regulatory consulting to clients and internal stakeholders.
• Liaise with competent authorities and regulatory agencies.
• Prepare, review, and maintain regulatory documentation and technical files.
• Support post‑market regulatory activities, including renewals, amendments, and ongoing compliance.
• Monitor regulatory changes and advise on their impact.

Required profile

• Bachelor's degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• Proven experience in medical device regulatory affairs.
• Strong knowledge of medical device regulations, registration processes, and regulatory submissions.
• Experience communicating with health authorities and competent regulatory agencies.
• Excellent regulatory writing, communication, and project management skills.
• Ability to work independently and manage multiple regulatory projects.

Required skills

What we offer

• Opportunity to collaborate on high‑impact medical device regulatory projects.
• Flexible engagement model based on project requirements.
• Potential for long‑term collaboration and full‑time employment as our regulatory services expand.