Medical Affairs Director/Senior Manager

About The Role

Medical Affairs Director/Senior Manager

Are you an expert in Medical/Clinical Affairs in Class III Implantable Devices?

Are you looking to take your next step into a leadership role?

Do you want to work with a global technology leader in regenerative medicine?

We are currently supporting our client headquartered in Germany to strengthen their clinical/medical affairs function. This is a remote role, so you can be based anywhere in Germany but must be willing to travel from time to time.

Does this sound like your next career step? **

Tasks**

• Management of a small team (2-5 employees)
• Ensure regulatory compliance for clinical trials and medical products on the market in accordance to MDR, TGA and FDA
• Pre-market and post-market clinical projects, including medical writing, CERs, PMS, and PMCFs
• Clinical trial project management (documentation, budget planning, collaboration with stakeholders on an international level as well as CROs)
• Reimbursement and compliance (Europe, especially Germany)

Your profile

• Degree in a scientific field such as biomedical, biology, medicine, medical engineering or a comparable field of study
• Experience in clinical (e.g. CER), regulatory affairs, bio-medical publication or medical writing, especially for class III implants
• Strong communication skills and project management experience
• Team player who can also work independently
• Knowledgeable in MS Office
• Fluency in English, German is a bonus

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.

may-lynn.ck@adaptivelifescience.com

+49 30 1663 7750