Amgen Senior Manager Regulatory Affairs - Digital Innovation Europe in Berlin, Germany

For our innovative Tech Hub, based in the heart of Berlin, we are currently seeking a Senior Manager Regulatory Affairs - Digital Innovation Europe. The successful candidate will primarily provide device regulatory subject matter expertise in the assigned regional Tech Hubs and regulatory guidance for technologies that are of interest to Amgen.

ADDITIONAL RESPONSIBILITIESResponsible for providing the regulatory considerations and strategies for product prototype development, proof-of-concept activities, partnership options and vendor due diligence

Develop, implement, communicate, and maintain regional regulatory plans for TDI/DH (Technology Innovation/Digital Health) initiatives/ projects

Perform device determinations for TDI/DH programs as needed

Provide support with review of external communications with hospitals, clinics and academic innovation centers as well as contracts, terms and conditions from a regulatory perspective.

Support TDI/DH technology & software development (including co-development and supplier management) efforts by providing regulatory guidance

Deliver ongoing device education and training to TDI/DH colleagues pertaining to innovation

Assist in training Amgen Affiliates with respect to regulatory requirements of developing TDI/DH products

Facilitate communication of changes in Regulations, Standards, and Policy which are likely to impact TDI/DH activities

Represent the EU Tech Hub/Amgen at external events

Responsible for developing and maintaining an overall EU process map to bring digital products to market

Collaborate with Device Regulatory International personnel who perform EU based (legal manufacturer) registrations

Help identify responsible quality contact as needed for project specific needs as well as help identify responsible legal contact as needed

MINIMUM REQUIREMENTSDoctorate degree and 2 years of relevant EU regulatory experience

OR Master's degree and 4 years of relevant EU regulatory experience

OR Bachelor's degree and 6 years of relevant EU regulatory experience

PREFERRED QUALIFICATIONS5+ years experience in EU device regulatory matters

Some regulatory experience in drug regulatory matters

Multi-sectoral awareness/exposure a bonus

Regulatory Device and Design Control experience

Software development in the healthcare sector

Experience working in cross-functional matrix organization

Fluent in English