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Regulatory Affairs Manager - Combination Products

Thousand Oaks, CA
Start date
Aug 9, 2022

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Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Biotech Beach, Best Places to Work
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Job Details


Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager Drug Devices and Combination Products


What you will do

Lets do this. Lets change the world. In this vital role you will support the development and delivery of regulatory strategies and filings for new and existing drug-device combination products and medical devices, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.

  • Support the development, communication, implementation, and maintenance of global drug-device combination product and medical device regulatory strategic plans
  • Lead and/or support health agency engagements (e.g. U.S. FDA)
  • Lead and/or support global filing activities and associated health agency inquiries
  • Support device design controls activities and documentation reviews
  • Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions
  • Perform change control regulatory assessments
  • Develop and support implementation and maintenance of internal regulatory processes
  • Perform device determination decisions for medical devices/drug devices/ combination products
  • Support supplier engagement teams and due diligence activities
  • Review regulatory sections in development, quality, and supply agreements
  • Engage in regulatory compliance initiatives
  • Collaborate and participate device external engagement initiatives


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a strong communicator with these qualifications.

Basic Qualifications:

  • Masters degree and 2+ years of Regulatory Affairs experience; OR
  • Bachelors degree and 4+ years of Regulatory Affairs experience

Preferred Qualifications:
  • Masters degree in Regulatory Affairs, Engineering, or Life Sciences with 2+ years of related regulatory experience is strongly preferred
  • May consider applicants with a Bachelors degree and 4+ years of combined experience including regulatory affairs, regulatory writing, regulatory device engineering and/or device quality experience, or other related drug-device combination products
  • Familiarity with medical device software is a plus
  • Outstanding written and verbal communication skills with a diversity of audiences


Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply nowfor a career that defies imagination

Objects in your future are closer than they appear. Join us.
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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.


We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.


Find Us
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
United States
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