Manager, Regulatory Affairs

Manager, Regulatory Affairs

The Manager Regulatory Affairs will be responsible for worldwide product approval submission activities. Plan and implement policies, procedures, practices, and strategies for the Regulatory Affairs. Collaborate with R&D, Clinical, and Quality functions to execute regulatory strategy from product inception to product launch.  Develop, document, and implement regulatory strategy for new technologies and product modifications.  Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings. Ensure the timely and accurate filing of regulatory documentation.  Interface with FDA, TUV, and other regulatory agencies regarding regulatory submission strategy and approval reviews.  Collaborate with Clinical to develop clinical trial plans and reports.  Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.  Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies.  Provide regulatory affairs support to the document control/change request system.  Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the company’s products.  A bachelor’s degree in a scientific/technical field is required; advanced degree is preferred.  Five years minimum experience in the medical device industry. Four to seven years experience in regulatory is required.  Class III experience is essential. Demonstrated experience in preparing IDE and 510(k) submissions for FDA; PMA submission experience desired.  Demonstrated experience with submissions to the European Union.  Experience with quality is preferred.

Please refer to job code SD6806 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Newton, MA
County:	Middlesex County
ZIP Code:	02458
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856