Job Summary

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. This position is responsible for managing all facets of regulatory support to market Zimmer Biomet products, developing regulatory submissions, managing departmental projects. In addition, the position will supervise the development and creation of labeling, provide guidance and consultation for domestic and international regulations and interact with governmental agencies. This position focuses on subject matter expertise, and may have responsibility for personnel management.

Principal Duties and Responsibilities

· Manages FDA regulatory submission process; may author and publish electronic submissions. · Provides regulatory direction to development project teams as a core team member, or lead a project team; develops and communicates regulatory strategy for new products. · Supports, supervises, and participates (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. · Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization. · Establishes Zimmer Biomet RA policy and procedures and ensures compliance with them. · Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products. · Communicates with Regulatory agencies. · Responsibility for oversight and prioritization of departmental tasks and projects.

Expected Areas of Competence

• Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors, peers, and direct reports. • 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. • Strong computer skills. • Able to identify and assess business risks and develop Regulatory strategy. • Strong product knowledge. • Ability to build relationships with other areas of the organization. • Ability to negotiate with Regulatory agencies, management, and other groups as necessary. • Ability to lead a team, influence others and. Strong organizational skills and development project experience qualify the occupant to lead teams and handle increasing levels of responsibilities.

Education/Experience Requirements

• US Bachelor’s (or non-US equivalent) degree in Life Sciences, Engineering or related field • 6-8 years of experience • Experience in orthopaedic or medical device strongly preferred • Regulatory Affairs Certification (US or EU) preferred.

Travel Requirements

Up to 15%

Additional Information

EOE M/W/Vet/Disability At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. Compensation range: $114,700 - $138,700