SR REGULATORY AFFAIRS ASSOCIATEPosted: November 13, 2009
SUMMARY OF POSITION: Perform diversified duties under general direction in order to meet domestic and international product submission and/or registration requirements. ESSENTIAL FUNCTIONS: 1. Participate as active and engaged members of new product development teams. 2. Conduct meetings with R&D, QE, Marketing and Clinical to assess/assign critical elements for new product submissions to FDA and international authorities (including, but not limited to performance testing, preclinical testing and clinical testing). 3. Determine product submission requirements, develop regulatory strategy, and apprise management to ensure adequate data is developed for product submission. 4. Prepare product registration dossiers, e.g., 510(k) submissions, PMAs, IDEs, international dossiers. Accountable for ensuring timely and accurate submissions in compliance with appropriate standards and content requirements. 5. Accountable for identification of submission risks and development of alternate courses of action in anticipation of regulators responses through scenario planning and contingency plans. 6. Interface with FDA and applicable EU Notified Body regarding regulatory submission strategies and approvals. 7. Correspond with international Covidien RA and distributors regarding requirements, dossiers and registration status. 8. Obtain product export certificates. 9. Review and approve product labeling ensuring compliance with current regulations. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: 1. Review industry newsletters and regulatory journals in order to monitor registration/regulatory requirements. 2. Attend product registration conferences and seminars. 3. Perform other related duties as assigned or warranted. Please refer to job code *59FEE38CA78EC04A when responding to this ad.
| Category: | Biotech/Pharmaceutical |
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> Regulatory Affairs
| | Location: | North Haven, CT | | County: | New Haven County | | ZIP Code: | 06473 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | Mallinckrodt | | Phone: | email only please | | Fax: | email only please |
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