24 days old

Regulatory Affairs Sr. Manager - Device

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118833340
Amgen

Job ID: R-95278
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Regulatory Affairs, Senior Manager-Device to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

The Regulatory Affairs - Device Team builds and leverages device and combination product GRAAS capabilities to continuously meet business objectives and compliance needs. This role establishes sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices (e.g., drug delivery devices, in-vitro diagnostics, software) and combination products.

Key Activities:

•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

Additional Activities that May Be Required:
•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

Knowledge and Skills:

•Change implementation
•Leadership
•Learning
•Negotiation
•Oral and written communication
•Planning and organization
•Prioritization
•Problem-solving
•Risk assessment
•Strategic thinking

Basic Qualifications:

Doctorate degree and 2 years of Regulatory Affairs, Life Sciences, Engineering related experience
OR
Master's degree and 6 years of Regulatory Affairs, Life Sciences, Engineering related experience
OR
Bachelor's degree and 8 years of Regulatory Affairs, Life Sciences, Engineering related experience
OR
associate degree and 10 years of Regulatory Affairs, Life Sciences, Engineering related experience
OR
High school diploma / GED and 12 years of Regulatory Affairs, Life Sciences, Engineering related experience

Preferred Qualifications:

•Degree in Regulatory Affairs, Life Sciences, Engineering or related field

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

•8 plus years of related experience in the medical device or combination product industry
•2 plus years of direct managerial and/or leadership experience

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 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.

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.

PI118833340

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95278<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Regulatory Affairs, Senior Manager-Device to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>The Regulatory Affairs - Device Team builds and leverages device and combination product GRAAS capabilities to continuously meet business objectives and compliance needs. This role establishes sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices (e.g., drug delivery devices, in-vitro diagnostics, software) and combination products.<br><br>Key Activities:<br><br>Develop, implement, communicate, and maintain global regulatory strategies and plans<br>Lead and/or support global filing activities and associated Health Agency meetings, including team reviews prior to submission<br>Review and approve device design control deliverables, as applicable per internal policies and procedures<br>Review standards and guidance for applicability; assist in establishing Amgen regulatory positions and communicating these to relevant stakeholders<br>Perform change management assessments; determine and communicate post-approval reporting requirements<br>Develop and support implementation and maintenance of regulatory processes<br>Lead and perform internal policy reviews for global regulatory guidance and regulations<br>Contribute to and participate in internal and external education and training activities<br>Identify and communicate relevant guidance, policies, standards, and regulations<br>Build and maintain effective relationships with internal and external stakeholders<br><br>Additional Activities that May Be Required:<br>Support supplier engagement teams and perform external due diligence regulatory activities<br>Advise on labeling requirements and perform regulatory review of labeling<br>Perform determination decisions for regulated items<br>Review regulatory sections in development, quality, and supply agreements<br>Support regulatory compliance initiatives<br>Recruit, hire, supervise and mentor regulatory staff<br>Represent Amgen at external events (e.g., PhRMA, PDA, BIO, DIA, AAMI, ISO), as appropriate<br><br>Knowledge and Skills:<br><br>Change implementation<br>Leadership<br>Learning<br>Negotiation<br>Oral and written communication<br>Planning and organization<br>Prioritization<br>Problem-solving<br>Risk assessment<br>Strategic thinking<br><br>Basic Qualifications:<br><br>Doctorate degree and 2 years of Regulatory Affairs, Life Sciences, Engineering related experience<br>OR<br>Master's degree and 6 years of Regulatory Affairs, Life Sciences, Engineering related experience<br>OR<br>Bachelor's degree and 8 years of Regulatory Affairs, Life Sciences, Engineering related experience<br>OR<br>associate degree and 10 years of Regulatory Affairs, Life Sciences, Engineering related experience<br>OR<br>High school diploma / GED and 12 years of Regulatory Affairs, Life Sciences, Engineering related experience<br><br>Preferred Qualifications:<br><br>Degree in Regulatory Affairs, Life Sciences, Engineering or related field<br><br>6 plus years' experience in Regulatory Affairs, including United States and international medical device and/or combination product regulations<br><br>8 plus years of related experience in the medical device or combination product industry<br>2 plus years of direct managerial and/or leadership experience<br><br><b>Amgen </b>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.<br><br><b>Amgen</b> 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.<br><br><b> Amgen </b> 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. <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/RD4WW6CllAndfPbefpLBV"> <p>PI118833340</p>

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Posted: 2020-03-07 Expires: 2020-04-07

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Regulatory Affairs Sr. Manager - Device

Amgen
Thousand Oaks, CA 91360

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