Senior Manager Regulatory Affairs – Digital Innovation Europe 295 views

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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At Amgen, we place immense value on fostering and enhancing the talents of our colleagues, as well as enabling their growth, both personally and professionally. Consisting nearly 20,000 individuals operating in nearly 100 countries, we utilize the industry’s largest toolkit of modalities, industry-leading partnerships and state-of-the-art technology and processes to ensure our world-class teams are well-equipped to maximize their potential.

Regularly recognized as a “Best Place to Work,” we enable staff to chart their own career paths by rewarding their contributions and future potential while encouraging fulfilling and meaningful careers through challenging assignments, active development and coaching, and individual rewards.

Offering a number of opportunities across a spectrum of disciplines, we promote open dialogue and diverse views within and amongst our departments. Coupled with modern working environments and a robust benefits package, we remain committed to providing careers that have a meaningful impact at work—and beyond.

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