Senior Manager, Corporate Regulatory Affairs

Senior Manager, Corporate Regulatory Affairs Requisition ID 31125 Full/Part Time x Location

Natick  MA

Description  Summary: The individual will be responsible for helping to set direction for Boston Scientific around the coordination and implementation of those programs that are required by government agencies, and providing consultation on corporate-wide regulatory requirements and compliance activities. The individual will be a key resource for corporate wide Sterilization and Operation initiatives, as well as product facility moves.  Responsibilities: • Monitors and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which Boston Scientific products are regulated around the world • Provides regulatory strategic support and direction to corporate-wide programs and initiatives including changes to sterilization and manufacturing locations, as well as corporate wide changes to sterilization activities and product materials. • Works closely with Divisional and Regional Regulatory Affairs, Corporate Operations, Corporate Sterilization, and Supply Chain on operations and sterilization initiatives. • Working in conjunction with Divisional and Regional Regulatory Affairs, may be responsible for submissions to Regulatory bodies that impact corporate wide activities (e.g., sterilization changes). • Supports other highly technical or major business initiatives, special projects, and strategic initiatives. • Provides technical guidance to Corporation during the course of strategy formulation and interaction with regulatory bodies, including assistance with internal and external audits • Leads the design, build, and implementation of programs and initiatives designed to improve the overall effectiveness of the Regulatory Affairs function. May also supervise staff driving these programs as well. • Facilitates development and maintenance of company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements • May attend meetings of medical device industry trade associations (e.g., AdvaMed, MDMA). • May direct and coordinate activities of Regulatory Affairs employees, including direct supervision. • Establishes project priorities, allocating resources and workload. • Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area supported.  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. • 3-5 plus years managerial/supervisory experience. • Overall understanding of global regulations. • Strong technical knowledge of medical products. • Experience in medical device manufacturing, sterilization operations, and validation is preferred. • Thorough understanding of regulations and standards associated with sterilization and validation. • 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. Up to 20% travel may be required.

Please refer to job code stonscientific-31125 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Natick, MA
County:	Middlesex County
ZIP Code:	01760
Pay Rate:	Open
Job Terms:	full time
Company:	Boston Scientific
Phone:	email only please
Fax:	email only please