Regulatory Affairs Specialist

About the role

Develop global regulatory strategies for software medical devices, ensuring ongoing compliance throughout the product lifecycle and managing submissions across key markets.

Key responsibilities

• Develop global regulatory strategies for software medical devices and ensure ongoing compliance throughout the product lifecycle.
• Prepare, coordinate and file regulatory submission documents for the US, Europe and Canada, and manage approvals.
• Represent Regulatory Affairs on cross‑functional teams, providing guidance for product development, audits and market releases.
• Communicate successful registration and regulatory approval to the business for commercial release.
• Maintain existing regulatory filings, licences and manage updates, supporting internal and external audits.

Required profile

• Bachelor’s degree in biological sciences, biomedical engineering or equivalent.
• 3‑5 years of work experience, including at least 1 year in the medical device industry.
• Ability to review and provide critical feedback on design documentation.
• Experience interacting with regulatory agencies and consultants.

Required skills

• Knowledge of ISO 13485, IEC 62304 and ISO 14971 standards.
• Familiarity with EU Medical Device Directive (MDD) and Medical Device Regulation (MDR).
• Proficiency with Microsoft Office applications, including Copilot.
• Regulatory Affairs certification (preferred).

What we offer

• Base salary range €48,611 – €81,018 per year.
• Annual bonus of up to 3% linked to performance and company results.
• Opportunity to work on global medical device software projects within a leading health‑technology company.