Manager, Regulatory Affairs

Manager, Regulatory Affairs Requisition ID 31473 Full/Part Time x Location

Marlborough  MA

Description  Summary: Responsible for multiple product lines, technologies and specialized functions. Devotes a significant portion of time to managerial, leadership and employee development responsibilities. Responsibilities: • Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team. • Provides day to day management of Regulatory Affairs function for major divisional business segment. • Establishes project priorities, allocating resources and workload. • Provides technical guidance to team during the course of strategy formulation, submission preparation and interaction with regulatory bodies. • Reviews and edits submissions prepared by staff. • Represents Regulatory Affairs at management updates.  • Provides long range strategy formulation.  • Develops and implements departmental policy and procedures.  • Provides Regulatory Affairs training/mentoring to other employees. • Support and maintain quality initiatives in accordance with BSC Quality Policy. • Continuously assess ways to improve Quality. • Acts 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.  • Develops and implements regulatory strategies for new and modified products.  • Oversees preparation and submission of global regulatory applications as well as internal regulatory file documentation. • Oversees review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes. • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations. • Supports highly technical or major business segment product lines, special projects and strategic initiatives. Qualifications: • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline. • 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. Working Conditions: General office environment, with potential (domestic and international) travel to BSC facilities and other meetings

Please refer to job code stonscientific-31473 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Marlborough, MA
County:	Middlesex County
ZIP Code:	01752
Pay Rate:	Open
Job Terms:	full time
Company:	Boston Scientific
Phone:	email only please
Fax:	email only please