Regulatory Affairs Specialist – Medical Devices
To contribute to a dedicated, cross functional and energetic project team implementing the new EU Medical Device Reporting (MDR) requirements.
- Organize and implement strategies and activities required to procure regulatory approval for new and revised product lines.
- Ensure compliance to all US, EU and international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products.
- Contribute to ensuring safety and efficacy on a wide range of products.
- Prepare regulatory submissions dossiers and follow-up with FDA and other regulatory agencies on submissions, approvals or related matters.
- Support R&D, marketing and manufacturing teams in regulatory assessment of proposed changes or product transfers.
- Provide regulatory support in cross functional team activities, as required.
Qualifications and Experience:
- Bachelor’s Degree in a scientific discipline. Ideally, you dispose of a RAC certification.
- 2-3 years’ experience in a highly regulated industry and working knowledge of Medical Device Regulations (FDA/MDD required, additional international a plus).
- Experience with 510(k), EU MDD 93/42/EEC Technical File/Design Dossier preparation.
- A successful track record interacting with FDA and notified body reviewers/inspectors.
- Fluent in both written and spoken English. Any additional language is an asset.
- Relevant working/residency permit or Swiss/EU-Citizenship required