Amgen

Regulatory Affairs Senior Manager - Devices and Combination Products

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Oct 06, 2021
Ref
R-117168
Required Education
Bachelors Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Regulatory Affairs Senior Manager - Devices and Combination Products

Live

What you will do

Lets do this. Lets change the world. In this vital role you will develop and execute regulatory strategies and filings for new and existing drug-device combination products and delivery devices, establish sustainable processes, assure informed relationships, and deliver strategic outcomes.

  • Develop, communicate, implement, and maintain global regulatory strategic plans
  • Lead and/or support health agency meetings
  • 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; determine and communicate post-approval reporting requirements
  • Develop and support implementation and maintenance of internal regulatory processes
  • Perform device determination decisions for regulated items
  • Support supplier engagement teams and due diligence activities
  • Review regulatory sections in development, quality, and supply agreements
  • Support regulatory compliance initiatives
  • Support Amgen's combination product Key External Initiatives
  • Supervise and mentor staff and lead regulatory training activities

Win

What we expect of you

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

Basic Qualifications:
  • Doctorate degree and 4 years of Regulatory Affairs experience; OR
  • Masters degree and 6 years of Regulatory Affairs experience; OR
  • Bachelors degree and 8 years of Regulatory Affairs experience

Preferred Qualifications:
  • Masters degree in Regulatory Affairs, Engineering, or Life Sciences
  • 6 or more years of experience in Regulatory Affairs
  • 8 or more years of experience in medical device and software

Thrive

What you can expect of us

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

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.


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.