Regulatory Affairs Manager, Medical Devices, Combination Products ( US-Remote)

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager - Medical and Drug-Device

What you will do

Let's do this. Let's change the world. In this vital role you will support the development and delivery of regulatory strategies and filings for new and existing drug-device combination products and medical devices, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes.

• Support the development, communication, implementation, and maintenance of global drug-device combination product and medical device regulatory strategic plans

• Lead and/or support health agency engagements (e.g. U.S. FDA)

• Lead and/or support global filing activities and associated health agency inquiries

• Support device design controls activities and documentation reviews

• Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions

• Perform change control regulatory assessments

• Develop and support implementation and maintenance of internal regulatory processes

• Perform device determination decisions for medical devices/drug devices/ combination products

• Support supplier engagement teams and due diligence activities

• Review regulatory sections in development, quality, and supply agreements

• Engage in regulatory compliance initiatives

• Collaborate and participate device external engagement initiatives

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a strong communicator with these qualifications.

• Master's degree and 2+ years of Regulatory Affairs experience; OR

• Bachelor's degree and 4+ years of Regulatory Affairs experience

• Master's degree in Regulatory Affairs, Engineering, or Life Sciences with 2+ years of related regulatory experience is strongly preferred

• May consider applicants with a Bachelor's degree and 4+ years of combined experience including regulatory affairs, regulatory writing, regulatory device engineering and/or device quality experience, or other related drug-device combination products

• Familiarity with medical device software is a plus

• Outstanding written and verbal communication skills with a diversity of audiences

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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Objects in your future are closer than they appear. Join us.