Senior Regulatory Affairs Specialist

 

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

 

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 planning, authoring, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product approvals and registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact assessment and approvals.

 

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

 

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

 
Your responsibilities will include: 

• Develop global strategies for regulatory approval of all medical device classifications
• Coordinate, author, compile, and submit U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, CE Mark submissions under MDR and US clinical investigation submissions
• Support requests from BSC International Regulatory personnel related to submissions, registrations, and change assessments and from clinical personnel related to international clinical investigation submissions
• Develop and maintain positive relationships with regulatory body reviewers
• Review Technical and Labeling documentation for inclusion in regulatory filings or as part of design changes
• 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
• Support regulatory audits, as required
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures

 

Required Qualifications:

• A minimum of a Bachelor's Degree
• A minimum of 4 years of regulatory affairs or related experience
• Demonstrated experience authoring a variety of regulatory submissions for US and EU
• Basic submission and presentation related computer skills, including experience with 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 or software devices
• Strong technical, research and problem-solving skills
• Ability to articulate complex ideas clearly both verbally and in writing
• Team player with excellent interpersonal and communication skills
• Demonstrated ability to effectively manage multiple projects and priorities
• Works well in fast-paced cross-functional team environments 

 

#LI-Hybrid

 

 

 

Requisition ID: 612418

Minimum Salary: $82600 

Maximum Salary: $156