Our client is a reliable partner for contract manufacturing organizations (CDMO), delivering high-quality solutions from ideation to market launch and series production for medical device and pharmaceutical companies. We are looking for a Regulatory Affairs Manager (f/m/d) for direct placement at the Aachen site
Here's what our clients offer
1. Performance - and market-driven pay
2. Company pension scheme
3. International working environment
4. Exciting work
5. Secure workplace
6. Support for further development
7. and much more.
Your tasks
8. You will be involved in the further development of regulatory affairs and QM systems in accordance with MDR and ISO 13485
9. You coordinate international approval and registration procedures for medical devices containing medicinal products
10. You create and maintain technical documentation and communicate with customers, suppliers and authorities worldwide
11. You process requests from authorities and research country-specific approval requirements
12. You support R&D, production and logistics with regulatory compliance and quality issues
13. You maintain change management and support design and process changes
14. You prepare and conduct audits, including communication with customers and authorities
Your profile
15. You have a degree in natural sciences, biomedical engineering or a comparable qualification
16. You have experience in medical technology, ideally also in the validation of sterilization processes (ETO)
17. You are familiar with the regulatory requirements for medical devices in the EU (EU MDR, ISO standards, MPDG); knowledge of the pharmaceutical sector (AMG, GMP) and internationally (US FDA) is an advantage
18. You have a good understanding of medical devices and functional drug coatings
19. You work independently, in a structured and team-oriented manner
20. You are experienced in using MS Office, Adobe Acrobat and QM systems in accordance with EN ISO 13485
21. You have a very good command of written and spoken German and English