Job Description

Job Summary

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 requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.

Principal Duties and Responsibilities

* Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
* Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates
* Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products
* Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
* Evaluates risk of proposed regulatory strategies and offers solutions
* Reviews proposed labeling for compliance with applicable US and international regulations
* Writes, manages, and approves the development of package inserts
* Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations
* Reviews proposed product changes for impact on regulatory status of the product
* Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams
* Follows Zimmer Biomet regulatory affairs policy and procedures
* May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
* Communicates with regulatory and governmental agencies
* Miscellaneous responsibilities as assigned

Expected Areas of Competence

Demonstrated strong writing and communication skills

Strong interpersonal skills and attention to detail

Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities

Proficient knowledge of overall business environment, the orthopaedic industry and the marketplace

Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicable

Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization

Able to identify risk in regulatory strategies

Robust product knowledge

Advanced anatomic knowledge

Proven analytical and negotiation skills

Experience with solving problems and concerns

Intermediate computer skills, including Microsoft Office Suite

Ability to lead a team and influence others

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

Education/Experience Requirements

US Bachelors Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered.

Advanced degree preferred

A minimum of 5+ years of experience in Regulatory Affairs, Engineering, Quality, or related field required

A minimum of 2 years of experience in orthopedic or medical device industry preferred

Regulatory Affairs Certification (US or EU) preferred

A combination of education, experience, leadership, strategy and RA influence may be considered

Travel Requirements

Up to 15%

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.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

Compensation Range: $87,800 - $103,300