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.
Regulatory Affairs Manager Drug Devices and Combination ProductsLive
What you will do
Lets do this. Lets change the world. In this vital role you will support the development and delivery of regulatory strategies and filings for new and existing drug-device combination products and medical devices, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.
- Support the development, communication, implementation, and maintenance of global drug-device combination product and medical device regulatory strategic plans
- Lead and/or support health agency engagements (e.g. U.S. FDA)
- 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
- Develop and support implementation and maintenance of internal regulatory processes
- Perform device determination decisions for medical devices/drug devices/ combination products
- Support supplier engagement teams and due diligence activities
- Review regulatory sections in development, quality, and supply agreements
- Engage in regulatory compliance initiatives
- Collaborate and participate device external engagement initiatives
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a strong communicator with these qualifications.Basic Qualifications
- Masters degree and 2+ years of Regulatory Affairs experience; OR
- Bachelors degree and 4+ years of Regulatory Affairs experience
- Masters degree in Regulatory Affairs, Engineering, or Life Sciences with 2+ years of related regulatory experience is strongly preferred
- May consider applicants with a Bachelors degree and 4+ years of combined experience including regulatory affairs, regulatory writing, regulatory device engineering and/or device quality experience, or other related drug-device combination products
- Familiarity with medical device software is a plus
- Outstanding written and verbal communication skills with a diversity of audiences
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 nowfor a career that defies imagination
- 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
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.