Job Information
Zimmer Biomet Principal Regulatory Affairs in Warsaw, Indiana
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
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, and interacting with governmental agencies. An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations and their application is required.
How You'll Create Impact
Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
Researches, analyzes and communicates information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research
May assign 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 of the product
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, advice, and guidance to the organization
Assist in the development and influence of regulations and standards where applicable
Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them
Provides training and/or guidance to all RA levels
Communicates with regulatory and governmental agencies
Responsible for oversight and prioritization of departmental tasks and projects
Directs and oversees the work of regulatory professionals, including training and mentoring
Miscellaneous responsibilities are assigned
This is not an exhaustive list of duties or functions and might not nece s sarily comprise all of the e s sential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, and peers
Strong interpersonal skills; ability to lead a team and influence others
Strong attention to detail
Strong organizational, problem-solving and analytical skills
Advanced negotiation skills; ability to negotiate with regulatory agencies, management and other groups as necessary
Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace
Mastery of relevant regulations and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products as applicable
Ability to functional well as a member of the team, team leader, and building relationships between RA and other areas of the organization
Ability to identify and assess business risks to develop regulatory strategy
Mastery of product knowledge and industry history
Mastery anatomic knowledge
Ability to manage projects of various sizes and constitutions; handle increasing levels of responsibility; versatility, flexibility and willingness to work with changing priorities
Strong computer skills
Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU
Your Background
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 orthopaedic or medical device industry preferred
Regulatory Affairs Certification (US or EU) preferred
A combination of education and experience may be considered
Travel Expectations
Up to 20%
EOE/M/F/Vet/Disability
Zimmer Biomet
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