Manager II, Endoscopy Reg Affairs
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
About the role:
At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs.
Your responsibilities will include:
In this role, you will be responsible for product lines, technology, managerial, leadership, and employee development activities.
•Directs and coordinates activities of Regulatory Affairs employees.
•Assists in establishing project priorities, allocating resources and workload.
•Provides technical guidance to team during submission preparation and interaction with regulatory bodies.
•Reviews and edits submissions prepared by team members.
•Represents Regulatory Affairs at management updates.
•Provides short-range strategy formulation.
•Implements regulatory strategies for new and modified products.
•Assists with developing and implementing departmental policy and procedure.
•Provides Regulatory Affairs training/mentoring to employees.
•Assists with 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.
•Oversees preparation and submission of global regulatory applications as appropriate 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 product and manufacturing changes for compliance with applicable regulations.
•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.
What we’re looking for in you:
•Bachelor’s degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred
•10+ years Regulatory Affairs, Medical Device experience required including international experience
•4+ years of management experience required
•Demonstrated success in management of regulatory submissions activities including FDA and Notified Body experience
•Demonstrated success as the RA lead on large cross-functional development teams
•Submission experience for capital equipment, software, and electrical products preferred (FDA, PMDA, CFDA, ANVISA, Health Canada, TGA, etc.)
•Experience supporting manufacturing/operations driven projects and achieving change approvals globally per business expectations
•Strong understanding of product development process and ability to effectively partner cross-functionally to develop and influence sound product strategies
•Strong technical knowledge of medical products
•Strong technical understanding of relevant procedures, practices, and associated medical terminology
•Thorough knowledge of product development process and design control
•Excellent research and analytical skills
•Ability to manage multiple projects simultaneously
•Excellent written and oral communication, technical writing and editing skills
•Strong leadership, interpersonal and influencing skills
•Ability to work independently with minimal supervision
•Ability to collaborate with cross-functional partners/teams
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 423294