Regulatory Affairs Senior Manager - Devices and Combination Products

Amgen is searching for a Regulatory Affairs Senior Manager for medical devices and drug-device combination products. The Senior Manager will facilitate device platform and product development, global registrations, and lifecycle management by developing and executing regulatory strategies.

Key Responsibilities:

• Develop global regulatory plans to obtain clinical and commercial approvals for new products and changes
• Lead and/or support health agency meetings
• Lead and/or support global filing activities and associated health agency inquiries
• Support device design and development activities (e.g. design controls and human factors) and documentation reviews
• Perform regulatory reportability assessments for changes
• Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions
• Develop internal best practices and lead process improvement activities
• Support device supplier engagement and due diligence activities; review regulatory information in quality and supply agreements with partners and suppliers
• Support quality compliance activities
• Support Amgen's combination product external engagement initiatives

Basic Qualifications:

• Doctorate degree and 2 years ofRegulatory Affairs, CMC, medical devices, and/or combination product related experience
  OR
  Masters degree and 4 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experience
  OR
  Bachelors degree and 6 years ofRegulatory Affairs, CMC, medical devices, and/or combination product related experience
  OR
  Associates degree and 10 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experience
  OR
  High school diploma / GED and 12 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experience

Preferred Qualifications:

• Masters degree and 4 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experience
• Strong writing, communication, and presentation skills
• Regulatory experience with a drug-delivery device
• Some experience with drug Clinical or CMC Regulatory Affairs
• Basic knowledge of device software, SaMD, and digital health technologies (DHT) regulatory requirements

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

for a career that defies imagination

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request an accommodation.