Regulatory Affairs Specialist – Meditech & Consumer Healthcare

About the role

The Regulatory Affairs Specialist will serve as the primary point of contact with regulatory authorities for Meditech and Consumer Healthcare products. You will ensure market access and compliance throughout the product lifecycle, supporting corporate strategy, sales teams and other stakeholders.

Key responsibilities

• Manage all regulatory authority activities, including registration, variations, retention and renewal of Meditech and consumer products in assigned regions.
• Develop and implement regional regulatory affairs procedures for marketed and new products, maintaining up‑to‑date compliance status.
• Lead communication on submission requirements, review, approval and maintenance of technical documents for corporate projects.
• Act as the regulatory expert on project teams, integrating requirements and maintaining an accurate regulatory information database.
• Coordinate multiple projects, priorities and submission timelines while providing regular status reports.
• Support inspections, audits, post‑market activities and continuous improvement initiatives.
• Ensure product health and safety compliance with international standards.

Required profile

• Bachelor of Pharmacy or Diploma in Pharmaceutical Technology (or related field).
• 2–5 years of medical device regulatory experience.
• Strong organizational, analytical and detail‑oriented skills with ability to manage competing priorities.
• Ability to work independently or within a team and interact credibly with senior stakeholders.

Required skills

• Medical device regulatory processes.
• IVD registration.
• Medical software certification.