Regulatory Affairs Senior Manager – In-vitro Diagnostics

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-27338
The Senior Manager will establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement In Vitro (IVD) regulatory strategies and processes for IVDs as well as medical devices (e.g., drug delivery devices, software) and combination products.
Key Activities:
Develop, implement, communicate, and maintain global regulatory strategies and plans
Manage or support IDE submissions for IVD or for Companion Diagnostics
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
Additional Activities:
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
Recruit, hire, supervise and mentor regulatory staff
Represent Amgen at external events (e.g., PhRMA, PDA, BIO, DIA, AAMI, ISO), as appropriate
Basic Qualifications
Doctorate degree and 2 years of Regulatory experience
Master's degree and 6 years of Regulatory experience
Bachelor's degree and 8 years of Regulatory experience
Associate's degree and 10 years of Regulatory experience
High school diploma / GED and 12 years of Regulatory experience
Preferred Qualifications
Degree in Regulatory Affairs, Life Sciences, Engineering
6+ years of experience in Regulatory Affairs, including United States and international in vitro diagnostic regulations including medical device and/or combination product regulations
8+ years of related experience in in vitro diagnostic regulations including medical device or combination product industry
2+ years of direct managerial and/or leadership experience
Change implementation
Oral and written communication
Planning and organization
Risk assessment
Strategic thinking
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need 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.
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.

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