Senior Manager Regulatory Affairs

We are currently representing a very exciting High Risk Medical Device manufacturer in Germany.

You will be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Manager will require extensive knowledge of all applicable standards, regulations, and guidance to support pre- and post-market requirements, as well as the ability to make regulatory submissions and filings.

The ideal Senior Regulatory Affairs Manager will have:

• Extensive experience in medical device/orthopedics regulatory affairs, ideally Class 3
• Experience in clinical evaluation report writing for class 3 medical devices
• Detailed knowledge of the worldwide regulations and guidance for medical devices.
• Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements.
• Understanding of Quality Management Systems - FDA QSR, ISO 13485.
• Detail-oriented and excellent written and verbal communication skills.

The key responsibilities of the Senior Regulatory Affairs Manager are to:

• Liaise with different departments including Quality, R&D and Product Management to provide regulatory input
• Timely preparation and submission of regulatory applications (EG 510(k), CE Marking, Design Dossier, IDE, Supplements, Annual Reports, PMA and PMA supplements)
• Interface with regulatory reviewers through written and oral communications as needed and assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.
• Liaise with other departments as a Regulatory expert on cross-functional projects