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Regulatory Affairs Senior Manager

3 months ago

Washington, Washington, D.C., United States Amgen Full time

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 changesLead and/or support health agency meetingsLead and/or support global filing activities and associated health agency inquiriesSupport device design and development activities (e.g. design controls and human factors) and documentation reviewsPerform regulatory reportability assessments for changesAssess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positionsDevelop internal best practices and lead process improvement activitiesSupport device supplier engagement and due diligence activities; review regulatory information in quality and supply agreements with partners and suppliersSupport quality compliance activitiesSupport Amgen's combination product external engagement initiativesBasic 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 experiencePreferred Qualifications:Masters degree and 4 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experienceStrong writing, communication, and presentation skillsRegulatory experience with a drug-delivery deviceSome experience with drug Clinical or CMC Regulatory AffairsBasic knowledge of device software, SaMD, and digital health technologies (DHT) regulatory requirementsThriveSome 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 journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor 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 Opportunity Statement 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.