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Senior Associate, Device Regulatory Affairs

Company: Amgen
Location: Thousand Oaks
Posted on: June 15, 2019

Job Description:

Amgen is seeking a Device Regulatory Affairs, Senior Associate, to work in our beautiful Thousand Oaks, CA campus. This position reports to the Director of Regulatory Affairs.Responsibilities of the Senior Associate, Device Regulatory Affairs Position include:

  • Supporting the execution of global filings and associated Health Agency meetings
  • Supporting the development and maintenance of document management system structure and accessibility
  • Supporting execution of device design control deliverables, as applicable per internal policies and procedures
  • Support requests for device/combination product input from regional regulatory staff
  • Support change management assessments
  • Support the development and implementation of regulatory processes
  • Implement regulatory processes
  • Maintain regulatory SharePoint site(s) and document archive/intelligence database(s)
  • Build and maintain effective relationships with internal and external stakeholders
  • Perform determination decisions for regulated items
  • Contribute to and participate in internal and external education and training activities
  • Identify and communicate relevant guidance, policies, standards, and regulations to Device Regulatory staffBasic Qualifications Master's degreeORBachelor's degree and 2 years of regulatory or drug development experienceORAssociate's degree and 6 years of regulatory or drug development experienceORHigh school diploma / GED and 8 years of regulatory or drug development experiencePreferred Qualifications
    • A Master's degree in Regulatory, life science, or Engineering
    • Previous regulated industry, science or clinical practice experience
    • Good communication skills - both oral and written
    • Organizational skills - detail oriented and can deal with frequent changes in product activity
    • Project Management and/or Document Management System and/or SharePoint experienceAmgen 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 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.

Keywords: Amgen, Los Angeles , Senior Associate, Device Regulatory Affairs, Other , Thousand Oaks, California

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