Specialist, Regulatory Affairs

Teleflex Medical, a worldwide medical device manufacturer, is seeking a Sr. Regulatory Affairs Specialist to join our team in Research Triangle Park, NC
REQUIREMENTS
The Specialist, Regulatory Affairs will manage all U.S. FDA and Health Canada aspects of regulatory affairs for their assigned product lines. Responsible for regulatory strategies, submissions, labeling review, product change review, and for managing interactions with the FDA and Health Canada. Responsible for staying abreast of evolving U.S. and Canadian regulatory requirements.
Major Responsibilities:
- Participate as a member of the regulatory team within the business unit to implement the “regulatory strategic plan”.
- Participate as a member of “Technical Teams” for new and/or existing products. Evaluate and interpret regulatory requirements to meet project needs.- Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of US and Canadian submissions for new products, amendment/variation of approved products and submissions that support the maintenance of existing licenses.- Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.- Review and approve technical documents intended for submission.
- Review labeling, advertising and promotional labeling and ensure compliance to policies.
- Train, develop, and mentor co-workers as appropriate.Requirements:- B.A. or B.S. degree in the life sciences
- 3-5 years of experience in Regulatory Affairs- Knowledge and experience in one or more essential regulatory areas (US and Canadian marketing approvals; change assessment; advertising and promotional labeling; and quality systems)
- An understanding of project management skills is required
- Knowledge of and ability to interpret applicable regulations as well as ICH and US/Canadian guidelines- Excellent written and verbal communication skills and computer literacy are required- Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality are essential.Qualified applicants please forward resume to: [Click here for email]. Ref #BM032 in subject line. M/F/D/V/EEO.