The Regulatory Affairs Manager will be responsible for managing all facets of regulatory support to market Zimmer Biomet products. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, interacting with governmental agencies and managing a staff of regulatory professionals.
Principal Duties and Responsibilities:
- Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
- Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to affiliates.
- Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research.
- Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products.
- Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of 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.
- Writes, manages, and approves the development of package inserts. Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations.
- Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization.
- Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them.
- Provides training and guidance to entry-level associates, interns, specialists, and project managers.
- Communicates with Regulatory/Governmental agencies.
- Responsibility for oversight and prioritization of departmental tasks and projects.
- Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development
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 interpersonal, organizational, problem-solving and analytical skills; strong attention to detail • Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities • Advanced knowledge of overall business environment, the dental industry and the marketplace; strong product knowledge • 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 and team leader, as well as build relationships between RA and other areas of the organization • Ability to identify and asses business risks to develop Regulatory strategy • Mastery anatomic knowledge • Ability to handle increasing levels of responsibility • Ability to build and lead a strong RA team; ability to lead and influence others • Strong computer skills • Ability to negotiate with regulatory agencies, management, and other groups as necessary • Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable
• 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 medical device, drugs, biologics, and/or combination products, preferred • Regulatory Affairs Certification (US or EU) preferred • A combination of education, experience, leadership, strategy and RA influence may be considered