Principal Regulatory Affairs Specialist

Additional Location(s): US-MA-Cambridge; US-MN-Arden Hills

 

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 this role:
The Principal Regulatory Specialist is responsible for working on Boston Scientific’s 3D Mapping System.  They will plan, manage, and author regulatory submissions to the US FDA, EU notified bodies, as well as support world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews and maintenance of EU technical documentation.
 
This is a hybrid role (in office 3 days per week) based in Waltham, Massachusetts or Arden Hills, Minnesota.  
 
Your responsibilities will include:

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams
• Represents Regulatory Affairs on cross functional projects which may include new product development, design/manufacturing changes, and continuous improvement efforts
• Develops regulatory strategies for Class II and III electronic medical equipment devices
• Coordinates, compiles, and submits US 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 international regulatory partners with investigational device and commercial marketing applications
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Develops and maintains positive relationships with regulatory agency staff
• Lead and/or participate in regulatory audits, as required

 
Required Qualifications:

• Minimum of a Bachelor's Degree
• Minimum of 7 years of Regulatory Affairs experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
• 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
• Strong technical, research and problem-solving skills
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 
Preferred Qualifications:

• Experience working directly with FDA, notified bodies and/or international health authorities
• Prior experience with electrophysiology and/or capital equipment/software devices
• Able to work independently with minimal supervision
• Demonstrated leadership, strategic thinking, project planning, and project management skills
• Able to work well in fast-paced cross-functional team environments
• Ability to articulate complex ideas clearly both verbally and in writing
• Demonstrated ability to develop strong relationships with regulatory agency staff
• Demonstrated ability to effectively lead multiple regulatory projects and priorities
• Prior experience providing technical guidance, training, and/or mentoring to Regulatory Affairs and/or cross-functional peers

 

#LI-Hybrid

 

 

 

Requisition ID: 604593

Minimum Salary: $99100 

Maximum Salary: $188300 

 

The anticipated compensation listed above and the value of