Director, Regulatory Affairs - CA
Company Profile: A
manufacturer of rapid point-of-care diagnostic test devices, this company
utilizes a biotechnology approach (to identify novel proteins or combinations
of proteins that function as disease biomarkers) to create a portfolio of
diagnostic tests for cardiovascular diseases and drug overdose.
Responsibilities:
Director Regulatory Affairs is responsible 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:
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Direct and oversee the preparation, review and submission of 510(k) and
PMA applications, amendments, reports and correspondences;
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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;
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Provide advice to applicable company personnel regarding the regulatory
aspects associated with the product development activities;
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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;
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Research various product actions taken by FDA to gain insight into the
Agency’s rationale for such actions;
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Interact with other personnel with regard to the preparation, review and
approval of advertising and promotional materials for licensed biologic
products.
Requirements:
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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;
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Minimum of 5 years experience in a medical device or IVD regulatory affairs
environment and a minimum of 8 years industry or related experience;
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Demonstrated ability to interpret FDA and other regulatory agency
regulations and guidelines;
Minimum B.S. degree in science or health-related discipline.
Compensation & Relocation:
- Compensation: Based on experience. Company is willing to "offer what
it takes" (upwards of $140k) for outstanding candidate;
- Company provides full relocation package.
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