Zimmer Biomet Connected Health, LLC
Regulatory Affairs Associate Manager (612861) (Project Management)
Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. The occupant will have expertise in areas that include preparation of dossiers for product registrations outside the U.S.; preparation of submissions to the U.S. FDA; U.S. FDA regulations, including labeling regulations; regulations of countries outside the U.S. The occupant will have responsibility for supervising employees.
• Manages FDA regulatory submission process, including authoring and publishing electronic submissions. • Oversees the development of dossiers for registration of products in countries outside the U.S, including authoring and publishing electronic submissions. • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. • Reviews proposed labeling for compliance with applicable U.S. and international regulations. • Manages the development of package inserts. • Reviews and evaluates 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. • Establishes Zimmer RA policy and procedures • Provides assignment and supervision of tasks, training and or guidance to employees. • Responsible for overseeing the performance of exempt level employees
• Demonstrated strong writing and communication skills. • Strong attention to details, and ability to multitask. • Understands the overall business environment, the orthopaedic industry and the marketplace. • Mastery of relevant regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products. • Ability to function well as a member of the team and build relationships between RA and other areas of the organization. • Strong computer skills. • Able to identify and assess business risks for a given Regulatory strategy. • Ability to oversee day-to-day performance of employees, organize the function of a group, and provide leadership as necessary.
• Bachelor's Degree (4 year university degree) or ex-U.S. equivalent. Degree or background in life sciences, technical (engineering) or related field. • Regulatory Affairs Certification (S. or EU) preferred. • Minimum of 5 years prior RA experience. • Regulatory background should include the medical device area, and preferably should include orthopaedic experience. Experience in the areas of drug, biologics, and combination products regulations is also desirable. • A combination of education and experience may be considered.
Up to 15%
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the