A leading company in the Software and AI medical device company in Amsterdam and Rotterdam I'm looking for a Regulatory Specialist. This role involves orchestrating regulatory efforts to ensure optimal interactions with regulatory bodies and achieve regulatory approval for medical devices.
- Prepare regulatory documents like pre-submission requests and marketing clearance requests.
- Independently prepare document packages for regulatory submissions, including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications.
- Track and coordinate regulatory submission activities to ensure timeliness and commitments are met.
- Coordinate responses to regulatory agencies and notified bodies during the submission and approval process.
- Review and approve Engineering Change Orders in line with regulatory requirements.
- Review and approve test protocols supporting regulatory submissions.
- Ensure device labeling and advertising materials comply with regulatory submissions.
- Assist in regulatory compliance activities, including Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits.
- Maintain regulatory files and perform internal audits of the Quality Management System.
- Provide ongoing regulatory support and guidance to project teams.
- Interpret and apply regulations and guidance appropriately.
- Bachelor's degree in a relevant field.
- At least 5 years of experience in regulatory affairs within the medical device, biotech, or pharmaceutical environment.
- Knowledge and experience with ISO 13485, ISO 14971, 21 CFR 820, and IEC 62304.
- Strong written and oral communication skills.
- Familiarity with GMPs and GCPs.
- Experience with regulatory submissions in the US and EU, including 510(k), PMA, DeNovo, and/or Technical Files.
- Master’s Degree in Engineering, Quality, Regulatory, or related field.
- Prior experience working at the FDA.
- Regulatory compliance experience in the medical device area.
- Strong negotiation, communication, organizational, and time management skills
- Unique opportunity to contribute to the regulatory success of innovative medical device products in a dynamic and challenging environment.
- Hybrid working from both Rotterdam or Amsterdam office
- Competitive market salary and interesting secondary benefits
Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at firstname.lastname@example.org. This is an excellent opportunity to join a leading pharmaceutical company in a vital role, so act fast to secure your chance for an interview.