Principal Regulatory Affairs Specialist

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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.

At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work.  In the Urology division, we continually advance the quality of patient care with innovative urology solutions. As a Regulatory Affairs Specialist, you’ll support global submissions, ensure ongoing compliance, and help develop regulatory strategies for new and existing products. This role requires strong U.S., EU, China, and international experience to support our worldwide growth.

Your Responsibilities Will Include

• Review and sign off on product design control documentation to ensure regulatory compliance.
• Provide technical and regulatory guidance to cross-functional teams throughout new product development and design changes, coordinating inputs for regulatory submissions.
• Write and review documents for establishing and maintaining EU MDR Technical Files, including preparation for Notified Body submissions and updates due to product or regulatory changes.
• Support the development and review of responses to non-conformances from Regulatory Authorities, including the Notified Body.
• Act as the legal manufacturer representative, maintaining positive relationships with internal regulatory specialists and external device reviewers through oral and written communications regarding regulatory strategy, pathway development, testing requirements, and document submissions.
• Communicate new regulatory requirements and their implications to relevant stakeholders, products, and the Quality System.
• Provide regulatory feedback and guidance as a core member of manufacturing and remediation teams, coordinating team inputs for submissions.
• Work with Israeli MOH/AMAR on new product registrations and updates to current registrations.
• Assist in developing and implementing regulatory strategies for new and modified medical devices.
• Prepare and submit global regulatory applications and internal regulatory file documentation for new product registrations, renewals, and remediation.
• Support and participate in audits by presenting regulatory materials and responding to regulatory inquiries.
• Promote a work environment of continuous improvement that aligns with BSC’s Quality Policy, Quality System, and applicable regulations.
  
  

Required Qualifications

• Bachelor’s degree in a scientific, technical, or related field
• 8+ years of Regulatory Affairs experience in the Medical Device industry
• Knowledge of FDA, EU, and global medical device regulations for medical devices
• Experience with product development, design control, and global registration processes
• Working knowledge of regulatory requirements for capital equipment and invasive disposable devices
• Effective written and oral communication, technical writing and editing skills in both English & Hebrew
• Ability to manage several projects 
• Proficiency in Microsoft Office
  
  

Requisition ID: 624378

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!