Senior Manager

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

The Senior Manager will establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement In Vitro (IVD) regulatory strategies and processes for IVDs as well as medical devices (e.g., drug delivery devices, software) and combination products.

* Develop, implement, communicate, and maintain global regulatory strategies and plans * Manage or support IDE submissions for IVD or for Companion Diagnostics * 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:** * 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

* 6+ years of experience in Regulatory Affairs, including United States and international in vitro diagnostic regulations including medical device and/or combination product regulations * 8+ years of related experience in in vitro diagnostic regulations including medical device or combination product industry * 2+ years of direct managerial and/or leadership experience * 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 experience * Master’s degree and 6 years of Regulatory experience * Bachelor’s degree and 8 years of Regulatory experience * Associate’s degree and 10 years of Regulatory experience * High school diploma / GED and 12 years of Regulatory experience