Regulatory Affairs Manager

Responsibilities

• Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process.
• 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.
• Aids in 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.
• 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.
• Evaluates, reviews, and approves promotion and advertising material for compliance with applicable regulations.
• Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization.
• Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them.
• Communicates with Regulatory/Governmental agencies.
• Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development.
• Miscellaneous responsibilities as assigned.

Qualifications

• 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 orthopaedic 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 assess 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.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team; ability to lead and influence others.
• Strong computer skills.
• To handle increasing levels of responsibility.
• Ability to build and lead a strong RA team