Prepare and maintain technical documentation required for CE marking.
Compile clinical evaluation reports and supporting documentation.
Ensure compliance with the EU Medical Device Regulation (EU MDR) and applicable standards.
Coordinate with Quality Assurance, Production, and Research & Development departments.
Communicate with notified bodies and regulatory authorities.
Support audits and maintain documentation readiness.
Monitor regulatory updates and ensure continued company compliance.
Requirements
Bachelor’s degree in Pharmacy, Biomedical Engineering, or Life Sciences.
2–5 years of relevant experience.
Medical devices or pharmaceutical industry experience preferred.
Knowledge of regulatory documentation, CE certification, EU MDR, and ISO 13485.
Good English communication skills.
Strong attention to detail.
Ability to work under deadlines and collaborate effectively with different teams.