Medical Device Regulatory Affairs, Senior Manager

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 that will serve patient needs with innovative drug delivery devices.

Responsibilities of the Medical Device Regulatory Affairs, Senior Manager include:

• Develop, implement, communicate, and maintain global regulatory strategies and plans
• Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission
• Review and approve device design control deliverables, as applicable per internal policies and procedures
• Review standards and guidance for applicability; assist in establishing Amgen regulatory positions and communicating these to relevant stakeholders
• Perform change management assessments; determine and communicate post-approval reporting requirements
• Develop and support implementation and maintenance of regulatory processes
• Lead and perform internal policy reviews for global regulatory guidance and regulations
• Contribute to and participate in internal and external education and training activities
• Identify and communicate relevant guidance, policies, standards, and regulations
• Build and maintain effective relationships with internal and external stakeholders
• 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
• Represent Amgen at external events (eg, PhRMA, PDA, BIO, DIA, AAMI, ISO)

Basic Qualifications:

Doctorate degree and 2 years of Health Agency or Medical Device or Regulatory Affairs experience

OR

Master's degree and 6 years of Health Agency or Medical Device or Regulatory Affairs experience

OR

Bachelor's degree and 8 years of Health Agency or Medical Device or Regulatory Affairs experience

OR

Associate degree and 10 years of Health Agency or Medical Device or Regulatory Affairs experience

OR

High school diploma / GED and 12 years of Health Agency or Medical Device or Regulatory Affairs experience

Preferred Qualifications:

• Master's degree in Regulatory Affairs, Life Sciences, or Engineering
• 6 or more years of experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations
• 8 or more years of experience in medical device development, combination product, medical device software, and/or IVD, companion diagnostics product industry

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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 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

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.