Senior Regulatory Affairs Specialist - Capital Equipment / Software

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.                

 

At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. 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. 
 
About this role: 
The Senior Regulatory Specialist is responsible for activities which lead to and maintain regulatory approval to market devices.  Additionally, the Specialist is responsible for assessment of device changes for regulatory implications.

 

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN or Marlborough, MA.  You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 
Your responsibilities will include: 

• Develop domestic and international strategies for regulatory approval of Class I, II and III medical devices, specifically capital equipment with software
• 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 MDR Tech Docs.
• Experience working with capital equipment and/or software medical devices
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 

Preferred Qualifications:

• Strong technical, research and problem-solving skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Team player with excellent interpersonal skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments 

 

#LI-Hybrid

 

 

Requisition ID: 591975

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-so