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Regulatory Affairs Associate Director

Company: ASML
Location: Jacksonville
Posted on: September 12, 2020

Job Description:

Regulatory Affairs Associate Director (659002) 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, including managing and participating (as necessary) in: the development of regulatory submissions; departmental projects; development of or creation and review of labeling; provision of guidance and consultation for domestic and international regulations; interaction with governmental agencies and managing a staff of regulatory professionals. Additional responsibilities include contributing to the formulation of strategic plans and departmental budgets, representing the department in corporate general projects, and other administrative tasks as delegated.

Principal Duties and Responsibilities Directs the regulatory submission process; manages the authorship and publication of electronic submissions.

Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process.

May author and publish electronic submissions.

Directs the development of dossiers for registration of products.

Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products.

Directs development and review processes for proposed labeling for compliance with applicable regulations.

Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations.

Oversees 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.

May provide support or supervision to processes.

Interprets and applies regulations to business practices and provides regulatory input, advice, and guidance to the organization.

Establishes and/or approves Zimmer Biomet RA policy and procedures and ensures compliance with them; may include training RA team or cross-functional groups.

Communicates with all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products.

Communicates with (or assigns others to communicate with) Regulatory and/or governmental agencies.

Responsibility for establishing prioritization of departmental tasks and projects.

Directs and oversees the work of regulatory professionals, including training, mentoring, and ensuring professional development.

Serves as a departmental knowledge resource, counseling, advising, and training on all/most facets of departmental function.

Participates in the administration of the department by assisting with strategic planning, budget preparation, participation in corporate projects, and other administrative projects as are assigned.

Expected Areas of Competence Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including Regulatory agencies, superiors, peers, and direct reports.

Strong attention to details, and ability to multitask.

Ability to manage projects of various sizes, constitutions, and management of personnel.

Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs, combination products and IVDs as applicable.

Mastery of product knowledge and industry history.

Mastery anatomic knowledge.

Able to identify and assess business risks and develop Regulatory strategy.

Ability to negotiate with Regulatory agencies, management, and other groups as necessary.

Ability to building relationships between RA and other parts of the organization.

Ability to lead a team, influence others and, through strong organizational skills, handle increasing levels of responsibilities.

Management and direct supervision of personnel. Ability to make independent decisions on resources and performance.

Strong tactical and strategic thinking skills and administrative and leadership ability.

Advanced knowledge of overall business environment, the orthopaedic industry, and the marketplace.

Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside the US/EU.

Education/Experience Requirements Bachelor’s Degree (or non-US equivalent) required. Degree or background in life sciences, technical (engineering) or related field preferred.

Advanced degree strongly preferred.

Regulatory Affairs Certification (U.S. or EU) preferred.

The entrant should have minimum of 8 years prior RA experience.

The incumbent’s 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 minimum of two years of experience managing direct reports.

A combination of education and experience may be considered.

Travel Requirements Up to 25%

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.

Keywords: ASML, Jacksonville , Regulatory Affairs Associate Director, Other , Jacksonville, Florida

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