Regulatory Affairs Specialist
We’re partnering with a scaling MedTech company developing an innovative medical device solution. This is an opportunity to join a purpose-driven organization where regulatory activities directly support patient safety, product quality, and long-term market access.
You’ll play a key role in navigating evolving regulatory requirements and supporting cross-functional teams across the organization.
Key Responsibilities
- Support and help drive regulatory strategy across product development and market approvals (EU, US, and future markets)
- Prepare and maintain technical documentation and submissions (e.g. CE marking, FDA 510(k)); act as a key contact for regulators and Notified Bodies
- Track and interpret evolving regulations (EU MDR, FDA, ISO 13485) and translate them into practical business guidance
- Ensure compliance of technical files, labelling, and promotional materials
- Partner with Quality, Manufacturing, Design, and Clinical teams on regulatory impact of changes and innovations
Key Criteria
- Bachelor’s degree in biomedical, Mechanical, Quality Engineering, Health Sciences, or equivalent
- Working knowledge of EU MDR 2017/745, FDA 21 CFR 820, and ISO 13485
- Experience with risk management tools (e.g. FMEA) and regulatory/project planning
- Strong documentation and MS Office skills (Excel, Word, PowerPoint)
- Excellent written and verbal communication skills in English
- Proactive, self-driven, and comfortable working in a scaling, evolving environment
What’s on Offer
- Competitive salary and benefits package
- Opportunity to work on an innovative, patient-impacting medical device
- Exposure to regulatory activities across multiple markets
If this sounds like something you’d like to explore, feel free to reach out directly for a chat and share your CV.
?f.signorello@panda-int.com
? +31 (0)20 20 44 502