Amgen Regulatory Affairs, Senior Manager in Thousand Oaks, California

Amgen is seeking a Regulatory Affairs, Senior Manager to work in their Thousand Oaks, CA location. This position will report to Executive Director Regulatory Affairs.

The Regulatory Affairs division establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices (eg, drug delivery devices, in-vitro diagnostics, software) and combination products.

Responsibilities of the 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 Med-Device or Regulatory experience

OR

Master's degree and 6 years of Health Agency or Med-Device or Regulatory experience

OR

Bachelor's degree and 8 years of Health Agency or Med-Device or Regulatory experience

OR

Associate's 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

Preferred Qualifications:

  • MS Degree

  • Degree in Regulatory Affairs, Life Sciences, or Engineering

  • 6+ years experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations

  • 8+ years of experience in software development, medical device, IVD, companion diagnostics, and/or combination product industry

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.