Engaging, representing, being Black Swans
Your Life Science Career Partner
To join a young company where your ambitions match their need for a QA/RA Manager who can envision a long-term international strategy for regulatory approvals. You enjoy cross-functional and direct collaboration, illustrated in this role through the chance to coach your team on quality systems, help to build a department from scratch, and navigate the international market through a hands-on approach.
Be the go-to person for audits and write regulatory documents in English. You are already familiar with seeking regulatory approvals and defining, authoring, and maintaining processes. You have an extroverted approach to your fellow teammates and are not afraid to try new things. Further, you are motivated by working with the international market and can navigate regulations in the U.S. and EU, as the company will introduce its products to the international market very soon.
A rapidly growing high-tech company with a fresh approach to the development of hearing aids that focus on the connectivity, affordability, and accessibility of their products. Expanding internationally and developing fast, they need someone to envision a long-term plan, which is where you come into the picture. Joining the company at such an early stage means you’ll become part of a tight-knitted team of colleagues and have the freedom to determine the direction of your role.
- Relevant higher degree, preferably a master’s or Ph.D., although the exact degree is not of importance
- Several years of hands-on experience with FDA and MDR, which is a minimum requirement for you to succeed in this role
- Knowledge of QMS and SOPs
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.