The Principal Regulatory Affairs Specialist originates appropriate documents to obtain and maintain clinical and/or marketing privileges consistent with applicable government requirements.
· Plans, coordinates, and executes regulatory strategy and submissions to obtain and sustain commercial approvals. *
· Participates on project teams as primary Regulatory Affairs Representative providing appropriate information on regulatory issues and obtaining needed information to meet regulation requirements. *
· Reviews labeling for compliance with regulations and ensures that claims are sustained. *
· Acts as a Regulatory liaison with FDA/Notified Body/Health Canada on behalf of AMS to facilitate timely and favorable review of submissions and issues. *
· Maintains current knowledge base on existing and emerging regulations, standards and guidance documents.
· Reviews new projects to determine the nature and scope of regulatory involvement; has independent responsibility for determining and providing written regulatory strategies for new product ideas.
EDUCATION
· BA/BS technical field or scientific discipline
EXPERIENCE
· Five years minimum device industry experience
· Five years minimum direct regulatory medical device submission experience preparing domestic and international.
· Strong working knowledge and application of FDA regulations and requirements with the ability to integrate into projects
SKILLS
· Demonstrated strong interpersonal and organizational skills
· Strong oral and written skills to effectively communicate technical information and keep management informed
· Self motivated and committed to a team approach
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