Regulatory Affairs Associate

Zimmer, Inc.•Warsaw, IN

About The Position

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.

Requirements

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

Nice To Haves

Limited regulatory submission preparation experience a plus

Responsibilities

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