Companion Diagnostic Regulatory Affairs Manager
HOW MIGHT YOU DEFY IMAGINATION?
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.
Companion Diagnostic Regulatory Affairs ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will support in 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.
- Work with our international affiliates to support IVD/CDx approvals in different regions all around the world.
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 Or
- Masters degree and 2 years of Health Agency or Med-Device or Regulatory experience Or
- Bachelors degree and 4 years of Health Agency or Med-Device or Regulatory experience Or
- Associates degree and 10 years of Health Agency or Med-Device or Regulatory experience Or
- High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience
- MS Degree
- Degree in Regulatory Affairs, Life Sciences, or Engineering
- 6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations
- 8 plus years of experience in software development, medical device, IVD, companion diagnostics, and/or combination product industry
Some of the vast rewards of working here
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.
- 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comEqual 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 UsIf 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.