Regulatory Affairs Associate (605570)

Responsible for assisting the team with regulatory filings as necessary to market Zimmer products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an understanding of Zimmer products and their use as well as an understanding of the regulatory admissions process. May perform some or all of the following functions, depending upon their specific assigned focus:
Principal Duties and ResponsibilitiesContributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
Assists in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
May provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
Reviews proposed labeling for compliance with applicable US and international regulations
Writes package inserts
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Reviews proposed product changes for impact on regulatory status of the product
Expected Areas of CompetenceDemonstrated strong writing and communication skills
Strong attention to detail, ability to multi-task
Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products
Ability to function well as a member of the team and build relationships between RA and other areas of the organization
Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
Basic computer skills, including Microsoft Office Suite
Education/Experience RequirementsUS Bachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent).
No formal RA experience required, two years preferred
Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
A combination of education and experience may be considered
Travel RequirementsUp to 15%
Additional InformationThis is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

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