Director of Regulatory Affairs

Director of Regulatory AffairsResponsible for leading the day-to-day activities of Regulatory Affairs with specific emphasis on the preparation, review and evaluations of documents for FDA submission. Also responsible for assuring that all regulatory requirements/commitments are met with respect to the development and approval of new medical devices; providing regulatory advice to other functional areas with regards to the regulatory aspects of medical device development; interacting directly with FDA personnel via written correspondences, teleconferences and meetings; and, working in cooperation with R&D, Marketing and Medical Affairs, to identify, investigate, evaluate and shape strategy for all new products and technology opportunities.Specific Responsibilities:
Direct and oversee the preparation, review and submission of 510(k) and PMA applications, amendments, reports and correspondences;
Act as the primary liaison with the Food and Drug Administration with regard to assigned projects; responsible for FDA interactions including FDA/sponsor telephone conferences, meetings and general communications;
Provide advice to applicable company personnel regarding the regulatory aspects associated with the product development activities;
Keep up-to-date on new proposed regulations and guidelines published by FDA and apprise company personnel how these affect the day-to-day business of the company;
Research various product actions taken by FDA to gain insight into the Agency’s rationale for such actions;
Interact with other personnel with regard to the preparation, review and approval of advertising and promotional materials for licensed biologic products.
REQUIREMENTS
Specific experience and demonstrated knowledge in the design and process of clinical trials, including regulatory requirements, data collection and analysis, and preparation or regulatory submissions, including IDE’s, PMA’s and 510(k)’s;
Minimum of 5 years experience in a medical device or IVD regulatory affairs environment and a minimum of 8 years industry or related experience; Demonstrated ability to interpret FDA and other regulatory agency regulations and guidelines;
Minimum B.S. degree in science or health-related discipline.