Principal Regulatory Affairs Specialist – DACH

About the role

The Principal Regulatory Affairs Specialist will act as the strategic regulatory partner for CooperVision’s DACH cluster, guiding products from concept through launch and post‑market. Based remotely in Germany with occasional visits to the Darmstadt office, you will ensure market access and compliance with EU MDR and regional regulations.

Key responsibilities

• Develop and execute regulatory strategies aligned with commercial priorities across the DACH and selected Eastern European markets.
• Lead the preparation, review and approval of regulatory submissions, renewals, amendments and notifications for EMEA.
• Monitor regulatory changes, provide intelligence to leadership, and maintain relationships with competent authorities and notified bodies.
• Review and approve product labeling, artwork and ensure compliance with MDR and market‑specific requirements.
• Support technical documentation audits, respond to Notified Body queries and drive corrective actions.
• Mentor junior specialists and contribute to continuous improvement initiatives within EMEA Regulatory Affairs.

Required profile

• 6–10 years of regulatory experience in the medical device industry.
• Proven track record preparing and submitting EMEA regulatory filings.
• Experience supporting audits, technical documentation reviews and stakeholder partnership.
• Advanced degree and/or Regulatory Affairs Certification are preferred.

Required skills

• ISO 13485 knowledge
• EU Medical Device Regulation (MDR) expertise
• Regulatory submissions and market access processes
• Technical documentation review
• Electronic document management systems

What we offer

• Competitive compensation and comprehensive benefits package.
• Wellness platform, discounted contact lens scheme and mental‑health support.
• Extensive training, LinkedIn Learning access and career development opportunities.
• Inclusive, diverse global work environment.