Job Posting: Senior Regulatory Affairs Specialist (Medical Devices)
Location: Veneendaal, Netherlands
Type: Full-time, Permanent
We are seeking an experienced Senior Regulatory Affairs Specialist to support our European Regulatory Affairs team. This role is key in ensuring product compliance across European markets, acting as the Person Responsible for Regulatory Compliance (PRRC).
Key Responsibilities:
- Oversee regulatory compliance for medical devices in Europe, ensuring adherence to MDR and EU regulations.
- Participate in developing and reviewing technical files for new product launches.
- Manage regulatory labeling, including product instructions and marketing materials.
- Prepare and submit Manufacturer Incident Reports (MIRs) to European authorities.
- Lead and coordinate Post-Market Surveillance (PMS) activities.
- Collaborate with cross-functional teams to align on regulatory strategy and growth initiatives.
Qualifications:
- Strong knowledge of ISO 13485 and MDR
- Proven experience in writing and reviewing regulatory submissions (e.g., MDR technical files).
- Excellent organizational and communication skills, with fluency in English and dutch is a plus
- Ability to work both independently and collaboratively across teams.
Benefits:
- Comprehensive onboarding and tailored training programs.
- Generous vacation allowance and pension contributions.
- Wellness perks including fitness center access and employee assistance program.
- Flexible working options and an international, collaborative environment.