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Title Location Type Rate Apply
Regulatory Affairs Specialist West Chester, PA Perm/Full $55,000 to $70,000

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Regulatory Affairs Specialist
Overall Responsibilities:

Prepare regulatory documentation to support the marketing of new and modified SUSA/CMF devices (510(k)/NTF). Coordinate conversion of Canadian notifications to licenses. Review device labeling, including all graphic material. Prepare export certificates, medical device listings, annual establishment registrations for submission to the Food and Drug Administration (FDA). Assist group in maintaining regulatory database for all products. Provide support to Regulatory Manager for special projects as needed.

Duties & Other Responsibilities:

Prepare regulatory documentation for all general orthopedic and maxillofacial devices, including 510(k) submissions for FDA review. Interface with Product Development to obtain necessary information for US and Canadian submissions. Develop a plan and implement conversion of US regulatory documents to fit the new Canadian regulations. Review/approve Custom Device Requests. Review/approve Engineering Change Requests/Notices. Review/approve labeling: device labels, brochures, technique guides, bulletins, updates, etc. Review trade publications for Regulatory news (Gray Sheet, GMP Letter, etc. Prepare export certificates, medical device listings, and annual establishment registrations. Respond to requests for information on import detentions. Provide Regulatory input to Product Development Groups. Miscellaneous compliance issues. Maintain regulatory database - ongoing update of database with regulatory information.

Professional Experience & Educational Requirements:

Four + years of prior regulatory experience in medical devices. Knowledge of U.S. FDA medical device regulations and guidance. Familiarity with new Canadian regulations and guidance a plus. Excellent written and oral communication skills. Knowledge/understanding of database system required. Ability to handle multiple tasks and be detail oriented.

EDUCATIONAL REQUIREMENTS: BA/BS Degree or equivalent work experience.