Specialist II, Reg Affairs

at  Boston Scientific Corporation

Required qualifications

• Minimum of a Bachelor’s Degree
• Minimum of 3 years regulatory affairs or related experience
• Working knowledge of relevant US/EU regulatory requirements for medical devices including Quality Systems standards
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environment

Preferred qualifications

• Previous experience with Class II or III medical devices submission

ABOUT THIS ROLE:

This role will be responsible for working on Boston Scientific’s recently acquired novel Atrial Fibrillation technology, Pulsed Field Ablation (PFA) (FARAPULSE, Inc.). The FARAPULSE PFA System is the first PFA technology that received a CE Mark in Europe. PFA 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. With adequate supervision, the Regulatory Affairs Specialist II is responsible for ensuring continued compliance with regulatory agency approvals through change assessments. The position may also be responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
• Review of technical documents, and product literature and labeling
• Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Support regulatory audits, as required
• Support development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
• Develop and maintain positive relationships with regulatory body reviewers

Required qualifications

• Minimum of a Bachelor’s Degree
• Minimum of 3 years regulatory affairs or related experience
• Working knowledge of relevant US/EU regulatory requirements for medical devices including Quality Systems standards
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments

Preferred qualifications

• Previous experience with Class II or III medical devices submissions

Requisition ID: 568580
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!