Medical Device Regulatory Affairs, Senior Manager
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Amgen is seeking a Medical Device Regulatory Affairs, Senior Manager to work in our Thousand Oaks, CA location. The Device Regulatory Affairs department develops and implements medical device and combination product regulatory strategies and submissions bring innovative drug delivery devices to patients.
Responsibilities of the Medical Device Regulatory Affairs, Senior Manager include:
- Develop, implement, communicate, and maintain global regulatory strategies
- Lead and/or support health agency meetings
- Lead and/or support global filing activities and associated health agency inquiries
- Support regulatory review of device design controls activities
- Review device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions; and contribute to training activities
- Perform change control regulatory assessments; determine and communicate post-approval reporting requirements
- Develop and support implementation and maintenance of internal regulatory processes
- Support supplier engagement teams and perform external due diligence regulatory activities
- Advise on labeling requirements and perform regulatory review of labeling
- Perform determination decisions for regulated items
- Review regulatory sections in development, quality, and supply agreements
- Support regulatory compliance initiatives
- Support Amgen’s combination product Key External Initiatives
- Doctorate degree and 4 years of Medical Device or Regulatory Affairs experience; OR
- Master’s degree and 6 years of Medical Device or Regulatory Affairs experience; OR
- Bachelor’s degree and 8 years of Medical Device or Regulatory Affairs experience
- Master’s 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
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
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.
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.
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.
Job posted: 2020-12-23