IVD RAQM Manager
About the Role
Are you an experienced professional in the realm of Regulatory Affairs and Quality Management, actively seeking a transformative opportunity where you can play a pivotal role?
Are you eager to embrace the flexibility of delving into novel subjects, acquiring fresh skills, and contributing to a global position in the domain of quality and regulatory affairs?
We are assisting our client in Berlin, an innovative team at the forefront of women's healthcare technology. They are currently on the lookout for a qualified Regulatory and Quality Affairs Manager to join them in advancing their mission!
- Formulating and refining regulatory strategies, with a primary focus on the EU and FDA
- Managing communication with Notified Body and pertinent authorities
- Developing and maintaining technical documentation
- Implementing and upholding the Quality Management System in adherence to ISO 13485, IVDR, and FDA 510(k)
- Offering support during internal and external audits
- Ensuring the compliance of all processes and products with requisite requirements
- A degree in the medical/engineering field
- Over 5 years of hands-on experience in Regulatory Affairs and Quality Management, specifically within the medical device and in-vitro diagnostic sector
- Profound knowledge of regulatory requirements and standards, such as ISO 13485, EU-MDR, FDA, ISO 14971, IEC 62304
- Previous experience in creating technical files
- Fluent in English, with a professional level of German
Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.
+49 30 1663 7750