We are currently seeking an experienced and driven Regulatory Affairs Specialist to join our client's reputable medical device company based in Germany. Our client is a market leader in the production of a niche portfolio of medical devices, in which you will assist in the monitoring of regulatory requirements and stakeholder communication.
In this role, you will have the opportunity to:
- Develop strategies for obtaining approval from regulatory authorities
- Prepare high-quality submissions
- Assist cross-functional teams throughout life cycle process
- Prepare responses to questions raised by regulators
Qualifications/Requirements:
- Bachelor's degree or higher qualification
- At least two year's of relevant work experience within regulatory affairs
- Fluency in German at C1 level is mandatory
- Experience in medical devices
- Experience with SDS and eCTD is preferred
If you're passionate about quality assurance processes specifically relating towards regulation policies , we'd love hear from you!
