Amgen

Senior Associate, Device Regulatory Affairs

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 22, 2019
Ref
R-70537
Required Education
Associate Degree
Position Type
Full time
Amgen is seeking a Senior Associate, Device Regulatory Affairs position to work out of their Thousand Oaks, CA location. This position reports to the Director of Regulatory Affairs

Responsibilities of the Senior Associate, Device Regulatory Affairs Position include:
  • Support execution of global filings and associated Health Agency meetings
  • Support development and maintenance of document management system structure and accessibility
  • Support 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 development and implementation of 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 staff


Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of regulatory or drug development experience

OR

Associate's degree and 6 years of regulatory or drug development experience

OR

High school diploma / GED and 8 years of regulatory or drug development experience

Preferred Qualifications
  • Master's degree in Regulatory, life science, or Engineering
  • 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 experience