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For your reference, we have included the original job posting below.
Manager II, Reg Affairs
Job Number:
39081554
Company Name:
Boston Scientific
Job Location:
Maple Grove, MN US
Job Category:
Healthcare & Medical
Manager II, Reg Affairs
Manager II, Reg Affairs
Requisition ID 40145 Full/Part Time Full Time
Location
Maple Grove
MN
Description Purpose/Role Statement
Responsible for multiple product lines, technologies and specialized functions. Devotes a significant portion of time to managerial, leadership and employee development responsibilities.
Key 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. · 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. · Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented
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. • 5 plus years managerial/supervisory experience. • 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.
*May not include all essential functions of the job such as all of the job’s physical/mental requirements
