Reg Affairs Senior Specialist

Zimmer Biomet   •  

Westminster, CO

Industry: Medical Devices & Diagnostics

  •  

5 - 7 years

Posted 371 days ago

This job is no longer available.

Job Summary

This position requires an advanced understanding ofmedical devicesand their use as well as an understanding of the regulatory submissions process.

Principal Duties and Responsibilities

Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates
Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
Evaluates risk of proposed regulatory strategies and offers solutions
Reviews proposed labeling for compliance with applicable US and international regulations
Writes, manages, and approves the development of package inserts
Reviews, evaluations, and approves promotion and advertising material for compliance with applicable 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 and design teams
Follows Zimmer Biomet regulatory affairs policy and procedures
May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
Communicates with regulatory and governmental agencies
Miscellaneous responsibilities as assigned

Expected Areas of Competence

•Demonstrated strong writing and communication skills
•Strong interpersonal skills and attention to detail
•Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
•Proficient knowledge of overall business environment, the orthopaedic industry and the marketplace
•Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicable
•Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
•Able to identify risk in regulatory strategies
•Robust product knowledge
•Advanced anatomic knowledge
•Proven analytical and negotiation skills
•Experience with solving problems and concerns
•Intermediate computer skills, including Microsoft Office Suite
•Ability to lead a team and influence others
•Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU

Education/Experience Requirements

•US Bachelor’s Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered.
•Advanced degree preferred
•A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
•A minimum of 2 years of experience in orthopaedic or medical device industry preferred
•Regulatory Affairs Certification (US or EU) preferred
•A combination of education, experience, leadership, strategy and RA influence may be considered

Travel Requirements

Up to15%

Additional Information

EOE/M/W/Vet/Disability

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