What are the responsibilities and job description for the Medical Device Regulatory Affairs Specialist position at Synkriom?
JOB DESCRIPTION:
Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.
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
Skills:
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
Education:
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
Hourly Wage Estimation for Medical Device Regulatory Affairs Specialist in Warsaw, IN
$31.00 to $39.00
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