Job Description

**Job Summary** This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process, regulatory compliance of AI/ML products throughout their lifecycle, from development through commercialization. **Principal Duties and Responsibilities:** Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products Evaluates risk of proposed regulatory strategies and offers solutions Reviews proposed labeling for compliance with applicable US and international regulations Writes, manages, and approves the development of labeling (e.g. package inserts, product labels, GUI/splash screens) Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations Reviews proposed product changes for impact on regulatory status of the product Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams Follows Zimmer Biomet regulatory affairs policy and procedures May provide training and/or guidance to entry-level associates, analysts, interns, and specialists Communicates with regulatory and governmental agencies Miscellaneous responsibilities as assigned _This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act._ **Expected Areas of Competence (i.e., knowledge, skills and abilities)** + Demonstrated strong writing and communication skills + Strong interpersonal skills and attention to detail + Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities + Proficient knowledge of with current and emerging regulations for AI/ML technologies, including risk management guidelines, AI-specific regulatory pathways and best practices for AI product oversight + In-depth knowledge of global regulatory frameworks (e.g. FDA, MDR, ISO, IEC) and standards related to AI/ML technologies, including software as a medical device (SaMD) and digital health products + Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization + Able to identify risk in regulatory strategies + Robust product knowledge + Advanced anatomic knowledge + Proven analytical and negotiation skills + Experience with solving problems and concerns + Intermediate computer skills, including Microsoft Office Suite + Ability to lead a team and influence others **Education/Experience Requirements** + US Bachelor's Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered. + Advanced degree preferred + A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required + A minimum of 3 years of experience in medical device industry with a focus on AI/ML technologies, digital health products preferred + Regulatory Affairs Certification (US or EU) preferred + A combination of education, experience, leadership, strategy and RA influence may be considered **T** **r** **avel Requirements** Up to 15% Salary: 90-133k USD **What You Can Expect** **How You'll Create Impact** **What Makes You Stand Out** **Your Background** **Travel Expectations** EOE/M/F/Vet/Disability

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