20 days old

Senior Associate, Device Regulatory Affairs

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119096036
Amgen

Job ID: R-96492
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior Associate, Device Regulatory Affairs position to work out of their Thousand Oaks, CA location. This position would support device regulatory activities for diagnostics, combination products, and software. This position reports to the Sr. Manager 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


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.

PI119096036

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96492<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Senior Associate, Device Regulatory Affairs position to work out of their Thousand Oaks, CA location. This position would support device regulatory activities for diagnostics, combination products, and software. This position reports to the Sr. Manager of Regulatory Affairs<br><br>Responsibilities of the Senior Associate, Device Regulatory Affairs Position include:<br><ul><li>Support execution of global filings and associated Health Agency meetings</li><li>Support development and maintenance of document management system structure and accessibility</li><li>Support execution of device design control deliverables, as applicable per internal policies and procedures</li><li>Support requests for device/combination product input from regional regulatory staff</li><li>Support change management assessments</li><li>Support development and implementation of of regulatory processes</li><li>Implement regulatory processes</li><li>Maintain regulatory SharePoint site(s) and document archive/intelligence database(s)</li><li>Build and maintain effective relationships with internal and external stakeholders</li><li>Perform determination decisions for regulated items</li><li>Contribute to and participate in internal and external education and training activities</li><li>Identify and communicate relevant guidance, policies, standards, and regulations to Device Regulatory staff</li></ul><br><br><b>Basic Qualifications </b> <br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of regulatory or drug development experience<br><br>OR<br><br>Associate's degree and 6 years of regulatory or drug development experience<br><br>OR<br><br>High school diploma / GED and 8 years of regulatory or drug development experience<br><br><b>Preferred Qualifications </b> <br><ul><li>Master's degree in Regulatory, life science, or Engineering</li><li>Regulated industry, science or clinical practice experience</li><li> Good communication skills - both oral and written </li><li> Organizational skills - detail oriented and can deal with frequent changes in product activity </li><li> Project Management and/or Document Management System and/or Sharepoint experience </li></ul><br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/4eldJPs2EoqoCo6zuWPd8"> <p>PI119096036</p>

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Posted: 2020-03-17 Expires: 2020-04-17

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Senior Associate, Device Regulatory Affairs

Amgen
Thousand Oaks, CA 91360

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