Regulatory Affairs Specialist

Regulatory Affairs Specialist – Medical Devices

(EU MDR, Swiss MepV, Post-Market & Technical Documentation)

We are seeking a Regulatory Affairs Specialist to support and maintain regulatory compliance for a portfolio of medical devices across Europe and Switzerland
. This role will play a key part in managing technical documentation, regulatory submissions, and post-market regulatory activities
, working closely with internal teams and external stakeholders.

• Maintain and update regulatory and technical documentation in line with EU MDR, Swiss MepV, and legacy MDD
• Prepare, review, and manage technical files
  , including labelling, IFUs, UDI data, and risk management documentation
• Assess and implement product and documentation changes
  , ensuring ongoing regulatory compliance
• Register economic operators and medical devices in applicable regulatory systems and manage updates
• Monitor regulatory, standards, and guidance changes, assess their impact, and communicate updates internally
• Prepare and submit documentation to Notified Bodies and manage responses to regulatory queries
• Track and maintain regulatory approvals, certificates,
  Declarations of Conformity
  , and EC-REP / CH-REP documentation
• Support post-market regulatory activities
  , including PMS documentation, PSURs, PMCF, vigilance, FSCAs/FSNs
• Collaborate with Quality, Supply Chain, subcontractors, and external partners across the product lifecycle
• Support internal and external audits and ensure proper version control and document archiving

• Experience in Regulatory Affairs within Medical Devices
• Strong working knowledge of EU MDR
• Hands‑on experience with technical documentation and post‑market activities
• Experience interacting with Notified Bodies and regulatory authorities
• Understanding of PMS, vigilance, PSUR, PMCF
  , and change management processes
• Strong organisational skills and attention to detail
• Ability to work cross‑functionally in an international environment
• Fluency in German

• Experience with device registrations and regulatory databases
• Exposure to audits and inspections
• Experience working with EC-REP / CH-REP arrangements

This is a permanent, remote‑based position with occasional travel as required.

If you’re interested in learning more, feel free to reach out or apply below: