Principal Regulatory Affairs Specialist - Global Regulatory - Capital Equipment

Additional Location(s): US-MN-Arden Hills; Ireland-Galway; US-MA-Marlborough

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: 
This Regulatory professional will act as the primary Regulatory Affairs representative in projects and initiatives related to the Capital Equipment and Medical Electrical Equipment spaces. Additionally, this person is responsible for representing Regulatory Affairs within quality system projects and process changes, process ownership and audit support. 

  

Your responsibilities will include: 

• Perform as the Regulatory Affairs Lead team member on initiatives to transform how we address the unique needs of capital equipment life cycle within the quality system (from part creation, labeling and testing to distribution and servicing) 
• Collaborate with cross functional partners as the Voice of Regulatory to deliver innovative solutions for achieving and maintaining compliance in the areas of Capital Equipment, and Medical Electrical Equipment 
• Proactively influence global site and divisional partners and leadership in interpretation/understanding of new concepts and requirements and adoption of Best Practices. In addition, working to ensure understanding and translation of strategies, goals and the full scope of Business Transformation initiatives 
• Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for process efficiencies 
• Identify, establish business cases for, initiate and lead projects to address needs within the capital equipment space as needed as related to Regulatory Affairs 
• Actively participate in various Quality System Community of Practice forums as representative of Regulatory Affairs, assessing impact, and bringing awareness to Regulatory Teams across the divisions and regions 
• Actively participate in advocacy streams to get a pulse on regulation trends and expectation as well as benchmark against other industry leaders (current areas for connection include repair, cybersecurity, and others) 
• Author, revise and edit standard operating procedures and work instructions 
• Participate as the Regulatory Affairs SME in assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed 
• Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions 
• Participate in training and mentoring of staff 
• Participate in department systems development initiatives 

  

Required qualifications: 

• Minimum of a bachelor’s degree 
• Minimum of 5 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries  
• Experience working with Capital Equipment medical devices in Regulatory Affairs or related disciplines 
• Working knowledge of FDA, EU and/or international medical device regulations 
• Ability to read and interpret global regulations and standards 
• General understanding of product development process, design controls and quality system regulations 
• Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint)  

  

Preferred qualifications: 

• Degree or work experience in a scientific or technical discipline 
• Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization 
• Excellent written and oral communication, technical writing and editing skills 
• Excellent research and analytical skills 
• Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485) 
• Ability to manage multiple projects simultaneously 
• High sense of urgency and commitment to execution 
• Proven leadership, collaboration and influencing skills 
• Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions) 

 

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