Regulatory Affairs Specialist 3 (Medical Devices)

About the role

Responsible for driving regulatory strategy, ensuring product compliance, and supporting market access for medical devices across global and high‑surveillance markets.

Key responsibilities

• Drive and implement global regulatory strategies and roadmaps, aligning with product marketing, new‑product introductions and high‑surveillance country requirements.
• Lead regulatory planning and execution across the product lifecycle, including submissions, product registrations (e.g., CE Marking), labeling reviews and compliance protocols.
• Monitor and manage regulatory risks and product safety by conducting risk assessments, handling compliance issues in systems such as TrackWise, and driving corrective and preventive actions with cross‑functional teams.
• Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, R&D, Marketing) to support regulatory filings, certification processes, UDI/GTIN activities and continuous improvement of regulatory processes and systems.

Required profile

• At least 2 years of experience in Regulatory Affairs, Quality Compliance or Product Development within the medical‑device industry, with a Bachelor’s degree (or a Master’s degree without prior experience).
• Bachelor’s or Master’s degree in Biomedical Engineering, Health Sciences, Pharmaceutical, Business Administration, Law or a related field.
• Fluent communication in English.

Required skills

• Experience with TrackWise or similar regulatory compliance systems.
• Knowledge of CE Marking and UDI/GTIN processes.
• Risk‑assessment and regulatory‑submission expertise.