28 days old

Companion Diagnostic Regulatory Affairs Senior Manager

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    129878952
Amgen

Job ID: R-111801
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

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 reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Companion Diagnostic Regulatory Affairs Sr. Manager

Live

What you will do

Let's do this. Let's change the world. In this vital role you will lead and support establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.
  • Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
  • Developing regulatory strategies for assigned products to enable timely registration of both therapeutic and diagnostic products by regulatory agencies.
  • Providing regulatory leadership and input to internal teams involved with IVD/CDX development planning, including Diagnostic Development Teams, and to Joint Development Teams with diagnostic partners.
  • Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks such as regulatory (e.g. PMA, 510(k), IDE) submissions.
  • In collaboration with diagnostic partners and internal teams, preparing for and executing meetings with regulatory agencies.
  • Review and approval of key regulatory submissions to CDRH (as agreed with diagnostic partners) and corresponding therapeutic dossiers.


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 champion with these qualifications.

Basic Qualifications:

  • 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


Preferred Qualifications:

  • 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


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.



PI129878952
Posted: 2021-02-05 Expires: 2021-03-09

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Companion Diagnostic Regulatory Affairs Senior Manager

Amgen
Thousand Oaks, CA 91360

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