Regulatory Affairs Specialist

Zimmer Biomet is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for managing all facets of regulatory support to market Zimmer Biomet products.

• Developing regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, and interacting with governmental agencies.
• Managing systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process.
• Authoring and publishing electronic submissions, researching, analyzing and communicating information pertaining to the appropriate regulatory pathway for new or modified products.
• Interpreting results of research, assigning regulatory affairs (RA) professionals to serve on development project teams as core team members; communicating regulatory strategy for new products.
• Keeping all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products.
• Supporting, supervising, and participating (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status of the product.
• Writing, managing, and approving the development of package inserts, reviewing, evaluating, and approving promotion and advertising material for compliance with applicable regulations.
• Interpreting and applying FDA regulations to business practices and providing regulatory input, advice, and guidance to the organization.
• Assisting in the development and influence of regulations and standards where applicable, establishing Zimmer Biomet RA policies and procedures and ensuring compliance with them.
• Providing training and/or guidance to all RA levels, communicating with regulatory and governmental agencies, responsible for oversight and prioritization of departmental tasks and projects.
• Directing and overseeing the work of regulatory professionals, including training and mentoring, miscellaneous responsibilities are assigned.

• Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, and peers.
• Strong interpersonal skills; ability to lead a team and influence others.
• Strong attention to detail.
• Strong organizational, problem-solving and analytical skills.
• Advanced negotiation skills; ability to negotiate with regulatory agencies, management and other groups as necessary.
• Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace.
• Mastery of relevant regulations and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products as applicable.
• Ability to function well as a member of the team, team leader, and building relationships between RA and other areas of the organization.
• Ability to identify and assess business risks to develop regulatory strategy.
• Mastery of product knowledge and industry history.
• Mastery of anatomic knowledge.
• Ability to manage projects of various sizes and constitutions; handle increasing levels of responsibility; versatility, flexibility and willingness to work with changing priorities.
• Strong computer skills.
• Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
• Advanced degree strong preferred.
• 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU.
• A minimum of 3 years of experience in orthopaedic or medical device industry preferred.
• Regulatory Affairs Certification (US or EU) preferred.
• A combination of education and experience may be considered.

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