Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Manager, Regulatory Affairs
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
