Boston Scientific

Marlborough, MA, 01752, USA

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. 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 r

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