Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx

Additional Location(s):  N/A

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.                

 

You’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer diagnostic and treatment solutions for treating irregular heart rhythms and heart failure. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets. 

About the role: 
Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

 

As a Senior Regulatory Affairs Specialist within the Digital Health and Cardiac Diagnostics Regulatory team at Boston Scientific CRM, you will have the opportunity to support bringing state of the art life sustaining and life-saving technologies to patients worldwide. 

Your responsibilities will include: 

• Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
• Coordinates, compiles, and submits 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 
• Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
• Develops and maintains positive relationships with regulatory body reviewers 
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Support regulatory audits, as required

 

Required qualifications:

• A minimum of a bachelor's degree or equivalent work experience
• A minimum of 5 years work experience in regulatory affairs or related discipline (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in medical devices, pharmaceutical, or health care industry
• Working knowledge of relevant US/EU and/or International regulatory requirements for medical devices including Quality Systems standards
• Effective written and oral communication, technical writing and editing skills
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 

Preferred qualifications:

• Bachelor's Degree in life sciences, engineering, computer science or related field
• Previous experience with Class II or III medical devices submissions
• Experience working directly with FDA, notified bodies and/or international health authorities
• Experience working with Medical Electrical Equipment (MEE) and related IEC 60601 standards
• Experience working with medical device software

 

Requisition ID: 577566

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life