Sr. Regulatory Affairs Specialist

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POST DATE 8/23/2016
END DATE 12/19/2016

Zimmer Biomet Warsaw, IN

Warsaw, IN
AJE Ref #
Job Classification
Full Time
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Job Summary

This is an experienced level position in Regulatory Affairs (RA). This position requires an intermediate understanding of Zimmer Biomet products and their use as well as an understanding of the regulatory admissions process. Works under minimum supervision

Principal Duties and Responsibilities

*Coordinates the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions
*Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions
*Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
*Evaluate risk of proposed regulatory strategies; may offer solutions
*Reviews proposed labeling for compliance with applicable US and international regulations
*Manages the process of writing package inserts
*Reviews and evaluates promotion and advertising material for compliance with 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
*Establishes Zimmer Biomet RA policy and procedures
*May provide training and/or guidance to new entry-level associates

Expected Areas of Competence

-Demonstrated strong writing and communication skills
-Strong attention to detail, ability to multi-task
-Knowledge of overall business environment, the orthopaedic industry and the marketplace
-Mastery of relevant 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
-Able to identify risk in Regulatory strategies
-Able to train entry level RA associates
-Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred
-Basic computer skills, including Microsoft Office Suite

Education/Experience Requirements

-US Bachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent). Advanced degreepreferred
-A minimum of 5 years of experience in Regulatory Affairs. 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
-Regulatory Affairs Certification (US or EU) preferred
-Experience with US FDA IDE and PMA submissions is preferred


Up to 15%