Manager Regulatory Affairs

Manager Regulatory Affairs
The Manager Regulatory Affairs is responsible for multiple product lines, technologies and specialized functions.  The incumbent will devote a significant portion of time to managerial, leadership and employee development responsibilities.  Direct and coordinate activities of Regulatory Affairs employees, including direct supervision of related team.  Provide day to day management of Regulatory Affairs function for major divisional business segment.  Establish project priorities, allocating resources and workload.  Provide technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies.  Review and edit submissions prepared by staff.  Represent Regulatory Affairs at management updates.  Provide long range strategy formulation.  Develop and implement departmental policy and procedures.  Provide Regulatory Affairs training/mentoring to other employees.  Support and maintain quality initiatives in accordance with BSC Quality Policy.  Continuously assess ways to improve quality.  Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.  Develop and implement regulatory strategies for new and modified products.  Oversee preparation and submission of global regulatory applications as well as internal regulatory file documentation.  Oversee review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.  Review and signs-off on product and manufacturing changes for compliance with applicable regulations.  Support highly technical or major business segment product lines, special projects and strategic initiatives.  A bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline is required.  Professional certification(s) preferred.  9 plus years Regulatory Affairs medical industry experience preferred. 5 plus years managerial/supervisory experience preferred.  Overall understanding of global regulations.  Strong technical knowledge of medical products. Comprehensive understanding of relevant medical procedures, practices, terminology, and products.  Proficient knowledge of clinical trial strategy, study design and sponsor reporting requirements.  Thorough knowledge of product development process and design control.  Excellent research and analytical skills.  Excellent written and oral communication, technical writing and editing skills.  Ability to effectively manage multiple projects.  Strong organizational, leadership, interpersonal and influencing skills.  Proficiency with Microsoft Office.

Please refer to job code SD6808 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Berlin, MA
County:	Worcester County
ZIP Code:	01503
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856