Regulatory Affairs Manager - Device and Combination Products

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

We are looking for a Manager, Regulatory Affairs - Device and Combination Products for our Thousand Oaks, California location. San Francisco may also be considered.

The Device Regulatory Group will build and leverage device and combination product (CP) capabilities to continuously meet business objectives and compliance needs.

Key responsibilities of the position include:
• Perform Registrations and Filings
• Inform on guidance and requirements for global device/combination product (CP) clinical and commercial regulatory strategies, filings, and associated Health Agency meetings
• Contribute to device/CP regulatory planning documents
• Support execution of global device-specific filings and associated Health Agency meetings
• Support external reviews (eg, consultants, business partners) of device/CP strategies and filing content Regulatory Processes, Initiatives, Teams, and Governance
• Contribute to integration of device/CP commercialization and GRAAS processes
• Support development/implementation of regulatory processes and templates for device/CP commercialization interfaces
• Under supervision, review and approve device design control deliverables
• Support device/CP manufacturing change decisions
• Support device/CP regulatory compliance initiatives
• Perform policy reviews for device/CP global regulatory guidance/regulations
• Establish sustainable processes
• Assure informed relationships, and deliver strategic outcomes
• Support development and implementation of regulatory strategies and processes for both new and existing combination products (CPs) and innovative delivery devices

Other skills:
• Leadership (promoting new directions by examples; work through influence)
• Operation in global, fast-paced, complex, and dynamic environment
• Oral and written communication, to include presentations
• Working effectively in regulatory and cross-functional teams

Basic Qualifications:
Doctorate Degree
OR
Master's Degree & 3 years of Regulatory & Compliance experience in the bio-tech industry
OR
Bachelor's Degree & 5 years of Regulatory & Compliance experience in the bio-tech industry
OR
Associates degree & 10 years of Regulatory & Compliance experience in the bio-tech industry
OR
High school diploma/GED & 12 years of Regulatory & Compliance experience in the bio-tech industry

Preferred Qualifications:
• Degree in Regulatory Affairs, Life Sciences, Engineering or related field
• 5+ years of biologic, combination product and/or medical device experience
• International Regulatory Affairs experience [eg, CE marking; technical file/design dossiers; application of international device standards (eg, ISO 14971, ISO 13485, ISO 14155, ISO 11608) and medical device and/or combination product regulations]

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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.