Senior Regulatory Affairs Specialist

 

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, 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

Join our Peripheral Interventions Team, where we create the next generation of cryoablation systems designed to treat abnormal tissue. Our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions.

  

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. This role will contribute to new product development efforts, including the next generation of cryoablation systems, while also ensuring ongoing compliance with regulatory agency requirements, such as conducting change impact assessments.

 

At Boston Scientific, we value collaboration and synergy.  This role follows a hybrid work model, requiring employees to be in our local office in Maple Grove, MN at least three days per week.

  

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

 

Your responsibilities will include:

• Support the development of domestic and international strategies for Class II medical devices
• Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including pre-submissions, 510(k)s, and CE Mark submissions under MDR
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

 

Required Qualifications:

• Bachelor’s degree, minimum
• 4+ years of experience in Regulatory Affairs or a related discipline in the medical device industry (such as R&D, Quality, Clinical, Biocompatibility, or Labeling), with at least 2 of those years specifically in Regulatory Affairs
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 510(k)s and EU MDR technical documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat 

 

Preferred Qualifications:

• Previous experience supporting medical electrical equipment
• General understanding of product development process and design controls
• Working knowledge of US FDA, EU, and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Team player with excellent interpersonal skills

 

 

#LI-Hybrid

 

 

 

Requisition ID: 613962

Minimum Salary: $82600 

Maximum Salary: $156900 <