Regulatory Affairs Specialist (663641) at Zimmer US in Dover, Ohio

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.

Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. Primary responsibility will be leading the transition of the CE marked product portfolio to EU MDR 2017/745 compliance. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the EU MDR 2017/745 requirements, including technical documentation, General Safety and Performance Requirements (GSPR) and Declaration of Conformity (DoC) creation.

Principal Duties and Responsibilities

• Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the technical documentation process. May author and publish technical documentation.


• Familiarity with conformity assessment routes, product classification, and notified body technical documentation reviews.


• Assist with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for products. Work cross-functionally with different functional departments, to ensure that design history files, risk management files, manufacturing documents, etc. reflect appropriate international regulatory requirements. Perform regulatory reviews of post market surveillance requirements, including Post-Market Surveillance Plans, Clinical Evaluation Reports, and Post-Market Surveillance Reports/Periodic Surveillance Update Reports.


• Provides regulatory direction to development project teams as a core team member; works with external partners to achieve MDR compliant technical documentation for CE marked products, and develops regulatory strategy for new or existing products.


• Evaluate risk of proposed regulatory strategies; may offer solutions


• Reviews proposed labeling for compliance with applicable global regulations


• Assists with the development of package inserts and instructions for use to ensure regulatory requirements are appropriately implemented.


• Reviews and evaluates promotional and advertising material for compliance with applicable regulations


• Reviews proposed product changes for impact on regulatory status of the product. Supports international registration impact as a result of product transition to EU MDR compliance.


• Communicates with regulatory, notified body, and governmental agencies with supervision


• Process change notice documentation to support technical documentation and GSPR creation.

Expected Areas of Competence

• Strong writing, communication, and interpersonal skills


• Strong attention to detail; ability to multi-task and balance competing priorities


• Knowledge of overall business environment, the orthopaedic industry, and the marketplace


• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area


• Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels


• Knowledge of FDA, EU, and other regulatory body regulations


• Ability to identify risk in Regulatory strategies


• Strong problem solving skills


• Effective negotiating skills Basic computer skills, including Microsoft Office Suite

Education/Experience Requirements

• Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred


• A minimum of one year of experience in orthopaedic or medical device industry preferred


• A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required


• Regulatory Affairs Certification (US or EU) preferred


• A combination of education and experience may be considered

Travel Requirements

Up to 15%

Additional Information

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

EOE/M/F/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.