Senior Manager Regulatory Affairs - Digital Innovation Europe

Senior Manager Regulatory Affairs - Digital Innovation Europe

Location: Berlin, Germany Job Type: Full-Time Employer: Amgen 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 responsibilities

• Responsible 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 Reuirements

• Doctorate 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 Qualifications

• 5+ 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

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About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.