Sr. Regulatory Affairs Specialist - Electrophysiology

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: 
The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices.  Additionally, the Associate is responsible for assessment of device changes for regulatory implications.

 

In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets. 
 

Your responsibilities will include: 

• Develop 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 
• Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments
• Develop and maintain positive relationships with regulatory body reviewers 
• Review Technical and Labeling documentation for inclusion in regulatory filings
• Review product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• Review clinical study protocols and other clinical documentation, and assess clinical study related changes to determine regulatory impact 
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• A minimum of a bachelor's degree 
• A minimum of 5 years of regulatory affairs or related experience
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs.
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 

Preferred qualifications:

• Previous experience in the medical device industry with Class II or III device submissions
• Experience working directly with FDA, notified bodies and/or international health authorities 
• Experience working with capital equipment devices
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments 
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
   

Requisition ID: 574435

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 and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our