Zimmer Biomet Holdings, Inc.
Principal Regulatory Affairs
Remote · Remote
About the role
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 talent 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 included, respected, empowered and recognised.
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 as assigned |
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
Physical Requirements
Travel Expectations
Travel up to 20%
Salary Expectations:
$125,000 - $140,000
EOE/M/F/Vet/Disability