Position Title:

Regulatory Affairs Specialist Work Location:

Warsaw, Indiana Assignment Duration:

12

Months Position Summary:

Responsible for assisting the team with regulatory filings as necessary to market our organization products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.

Key Responsibilities:

Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions. Respond to requests from foreign government and/or distributors as needed Assist with the 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 Evaluate risk of proposed regulatory strategies; may offer solutions Reviews proposed labeling for compliance with applicable global regulations Writes and manages the development of package inserts Reviews and evaluations promotion and advertising material for compliance with applicable regulations Reviews proposed product changes for impact on regulatory status of the product Communicates with regulatory and governmental agencies with supervision Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams

Qualification & Experience:

Strong writing, communication, and interpersonal skills Strong attention to detail; ability to multi-task and balance competing priorities Knowledge of overall business environment, the orthopaedic industry, and the marketplace Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels Knowledge of FDA, EU, and other regulatory body regulations Ability to identify risk in Regulatory strategies Strong problem solving skills Effective negotiating skills 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 A minimum of one year of experience in orthopaedic or medical device industry preferred A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required Regulatory Affairs Certification (US or EU) preferred A combination of education and experience may be considered