Vice President, Clinical & Reg. Affairs - Northeast
QUALIFICATIONS:
• Experience in working with the FDA, and having their respect.
• Understanding of GLP. GMP, and Quality Management including ISO and CE mark certification.
• Filing successful 510-K submissions, PMA’s, IDE applications, PLA’s, BLA’s and working with other global notified bodies in gaining product approvals.
• Managing clinical trials and protocol development to successful end points, and commercialization of products on a global basis.
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• Provides expert Clinical, Regulatory, and Quality guidance to the Company, reflecting current thinking at the FDA and other global approval agencies that balance and weigh the Company’s commercial interests with the current Regulatory direction.
• Undergraduate degree in a technical discipline; an advanced degree desirable.
