Regulatory Affairs Specialist II - Electrophysiology Pulsed Field Ablation

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.                

 

About the role: 
You’ll discover a place where you can have meaningful purpose, improving lives through your life's work. Our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets.

 

This role will be responsible for working on our innovative Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. PFA technology is transforming ablation therapy on a global scale, and we are investing in portfolio development, robust clinical evidence, and global execution as we expand the capabilities and reach of this product with different indications.

 

With adequate supervision, the Regulatory Affairs Specialist II 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.

Your responsibilities will include: 

• Supporting the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
• Coordinating, compiling, and submitting 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
• Supporting requests from BSC International Regulatory related to submissions, registrations, and change assessment
• Developing and maintaining positive relationships with regulatory body reviewers
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Reviewing of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Representing RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Supporting regulatory audits, as required

 

Required qualifications: 

• A minimum of a Bachelor's degree in life sciences, engineering, or related field
• 2+ years in regulatory affairs or a combination of 3+ years in a related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling)
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 

Preferred qualifications: 

• Working knowledge of regulatory requirements for medical devices 
• Experience with Class II or Class III medical devices submissions
• Experience with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Experience working directly with FDA, notified bodies and/or international health authorities 
• Strong technical, research, problem-solving, and leadership skills 
• Ability to communicate complex ideas clearly and simply both orally and in writing
• Demonstrated ability to effectively lead multiple projects and priorities
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments

Requisition ID: 591092

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 ju