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Sterilisation Validation
The Consultant will lead and support sterilisation strategy, validation, and compliance activities across the full lifecycle of medical devices, including Class IIa. The role requires deep expertise in sterilisation modalities, microbiological testing, and regulatory frameworks under both FDA and EU MDR. Job Title: Sterilisation ValidationDuration:...
Validation and Verification Engineer
About the Role:We are seeking a Verification & Validation (V&V) Engineer to ensure compliance and process integrity for medical devices involving neutron activation technologies. This role focuses on validating complex processes within a regulated environment, ensuring adherence to international standards and supporting product performance requirem...
Process Development engineer Netherlands
Process Development EngineerContract Type: 12-Month Freelance Contract Industry: Medical Devices Location: Utrecht, Netherlands (Hybrid: 4 days on-site, 1 day remote)] We are seeking an experienced Process Development Engineer to join on a 12-month freelance basis. This role is critical to supporting process development and compliance within the me...
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Post-Market Surveillance Consultant
Post‑Market Surveillance Consultant (Medical Devices)Location: Eindhoven, Netherlands Contract length: 12 months Engagement: Freelance / ContractKey ResponsibilitiesLead and execute Post‑Market Surveillance activities in compliance with EU MDR 2017/745.Develop, maintain, and update PMS documentation, including:PMS PlansPMS Reports (PMSR)Periodic Sa...
Senior Field Clinical Specialist
Location: Nationwide (Netherlands) Travel: ~70% Function: Clinical Support / Cardiology Type: Field-BasedAbout the RoleA growing medical technology organisation is seeking a Clinical Specialist to join their dynamic team. This field-based role is ideal for someone with a strong background in cardiology, clinical practice, or catheterisation laborat...
Regulatory Affairs Director
Regulatory Affairs Lead / DirectorWe are looking for an experienced Regulatory Affairs professional to guide US and EU regulatory strategy for a complex medical device.What you will do* Lead the full US market entry strategy including 510k, De Novo or PMA routes * Run Q Sub and Pre Submission processes and prepare all submission documents * Act as ...