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 / In Vitro Diagnostics Regulatory Affairs ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will [top-line statement connecting primary position responsibility to employer brand].
Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.
Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities.
Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Project Teams with diagnostic partners.
Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE).
In collaboration with diagnostic partners and internal teams, preparing for and implementing meetings with regulatory agencies.
Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (as agreed with diagnostic partners) and corresponding therapeutic dossiers.
Interacting with international regulatory colleagues and diagnostic partners to determine standard processes & least burdensome regulatory paths towards development & global registration activities.
Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively.
Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these 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
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 IVD/CDx regulations
8 plus years of experience in medical device and/or IVD/CDx industry
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.
Apply now for a career that defies imagination
Full support and career-development resources to expand your skills, enhance your expertise, and increase 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
Objects in your future are closer than they appear. Join us.careers.amgen.com
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.
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.