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
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
Manages systems for assembly, distribution, storage, tracking
and retrieval of information pertinent to the regulatory
May author and publish electronic submissions.
Directs the development of dossiers for registration of
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
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
Serves as a departmental knowledge resource, counseling,
advising, and training on all/most facets of departmental
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
Ability to negotiate with Regulatory agencies, management, and
other groups as necessary.
Ability to building relationships between RA and other parts of
Ability to lead a team, influence others and, through strong
organizational skills, handle increasing levels of
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
The incumbent’s regulatory background should include the medical
device area, and preferably should include orthopaedic
Experience in the areas of drug, biologics, and combination
products regulations is also desirable.
A minimum of two years of experience managing direct
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.