Sr. Regulatory Affairs Manager - Electrophysiology

Additional Locations: N/A

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At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

Sr. Regulatory Affairs Manager

• Electrophysiology

About the role:

Sr. Regulatory Affairs Manager is a Regulatory Subject Matter Expert (SME) on multiple products, technologies and regions. Responsible for leading the day-to-day regulatory activities which includes team oversight, regulatory strategy guidance, and hands-on submission or other regulatory responsibilities. Responsible for resourcing, leadership, and employee coaching & development.

This role will be responsible for working on Boston Scientific's Pulsed Field Ablation (FARAPULSE) product portfolio. Pulsed Field Ablation technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications.

Your responsibilities will include:

• Provides regulatory expertise with respect to global regulatory strategy development, execution, and risk management.

• Directs and coordinates activities of Regulatory Affairs employees, including direct supervision of related team.

• Establishes and manages project priorities, allocating resources and workload to achieve business milestones.

• Participates in advocacy/outreach with Sr. franchise and functional leaders to achieve business objectives and assess commercialization pathway trade-offs.

• Provides regulatory expertise to facilitate entry into new therapeutic areas, technologies, and design; and new regulated regions such as emerging markets.

• Drives clarity into product approval and post market requirements through effective problem identification, communication, and use of regulatory agency network.

• Operates effectively as regulatory team lead on assigned projects including global regulatory strategy development and execution.

• Assesses and manages global dependencies and opportunities to coordinate regulatory efforts serving as liaison to both regional BSC RA personnel and Agencies, and internal functional and program management stakeholders.

• Capable of authoring and executing / supporting all aspects of Global Regulatory Strategies and submissions. Provides regulatory expertise and assessment for product and manufacturing changes.

• Collaborates with Regulatory Affairs functional peers from across BSC to establish procedures and best practices optimally utilizing our Regulatory Affairs talent.

• Supports New Business Development by performing regulatory due diligence on candidate companies and products/programs; provides initial regulatory project management for integration of new companies and products into the franchise structure; assesses RA resource needs and supports staffing and new employee integration as needed; acts as RA Core Team Member for Alliance and/or acquired PDP programs.

• Leads regulatory-related education efforts and mentoring in areas of expertise.

• Studies and understand applicability of relevant regulations to the business.

• Research competitive product regulatory approvals and pathways, and disseminates to relevant stakeholders.

• Provides litigation support, including research and depositions.

Supports Quality System and audit readiness through maintenance and provision of regulatory information to QA, Notified Bodies and FDA.

What we're looking for in you:

Minimum requirements

• A minimum of 6-8 years of experience in regulatory affairs in the Medical Device industry and a minimum of 1 years of experience in people management

• A minimum of a bachelor's degree is required.

• Demonstrated ability to lead and manage others, either through projects or direct management.

• Demonstrated success in regulatory submissions activities, such as 510k, IDE, PMA, and EU MDD/MDR CE Marking, and international registrations.

• Ability to effectively partner cross-functionally to develop and influence sound regulatory strategies.

• Ability to successfully manage multiple projects simultaneously and prioritize individual and team's assignments to meet the business needs.

• Excellent written and oral communication, technical writing, and editing skills.

• Strong leadership, interpersonal, and influencing skills.

• Proficiency with Microsoft Office

• Ability to work independently and prioritize workload with minimal supervision.

Preferred Qualifications

• Previous experience with the support of clinical studies

• Understanding and experience with global regulatory submissions

• Strong knowledge of Electrophysiology products

Requisition ID: 580037

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Compliance, Electrophysiology, Law, Clinical Research, Legal, Healthcare