Principal Regulatory Affairs Specialist

About the role: At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work.  In the Urology division, we continually advance the quality of patient care with innovative urology solutions. We have a robust product line and pipeline, and we will continue to make an investment in Urology treatments.  This role will be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. The ideal candidate will demonstrate flexibility in their work schedule to accommodate business needs and collaboration across teams 

Your responsibilities will include: 

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. 

• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. 

• Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships.   

• Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and international product registration. 

• Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions. 

• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation. 

• Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes. 

• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations. 

• Support and maintain Quality initiatives in accordance with BSC Quality Policy. 

• Continuously assess ways to improve Quality. 

• Develops and implements departmental and divisional policies and procedures. 

• Supports highly technical or major business segment product lines, special projects or strategic initiatives. 

 
Required qualifications: 

• A minimum of a Bachelor’s degree in a scientific, technical, or related discipline  

• A minimum of 7 years Regulatory Affairs experience in the medical industry  

• Prior experience supporting both capital equipment/medical electrical equipment and single-use disposable medical devices.   

• Prior experience with 510(k) submissions, EU MDR and international regulatory registrations.   

• Working knowledge of FDA, EU and international regulations for medical devices.  

• Ability to read and interpret global regulations and standards 

• General understanding of product development process, design control and quality system regulations.  

• General understanding of regulations applicable to the conduct of clinical trials.  

Preferred qualifications: 

• Prior experience supporting contract manufactured and/or OEM products.  

• Ability to simultaneously manage several projects.  

• Proficiency with Microsoft Office.  

• Effective research and analytical skills.  

• Effective written and oral communication, technical writing and editing skills.  

• Ability to work independently with minimal supervision.