Regulatory Affairs Associate (635848) (Finance)
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. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires a basic understanding of medical devices and their use as well as a basic understanding of the regulatory submissions process. May perform some or all of the following functions, depending on specific assigned focus.
· Coordinate and assist in the preparation of technical documentation for use in regulatory submissions worldwide · Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products · May aid in regulatory direction to development project teams as a core team member; supports regulatory strategy for new products · Reviews proposed labeling for compliance with applicable international and country regulations · Support development of package inserts · Reviews and evaluates promotion and advertising material for compliance with applicable regulations · Supports and reviews proposed product changes for impact on regulatory status of the product · Follows Zimmer Biomet RA policies and procedures · Miscellaneous responsibilities as assigned
Strong writing, communication, and interpersonal skills Strong attention to detail Strong problem-solving and analytical skills Ability to work with rapid changes; flexible and able to balance competing priorities Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to functional work team Self-motivated and capable to work in a diverse, fast-paced and dynamic environment Ability to build strong relationships; communicate effectively at all levels Basic computer skills, including Microsoft Office Suite
Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred Limited regulatory submission preparation experience a plus
Up to 10%
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. EOE/M/F/Vet/Disability