Principal/Senior Regulatory Affairs Specialist

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. As a Regulatory Affairs Specialist, you’ll support global submissions, ensure ongoing compliance, and help develop regulatory strategies for new and existing products. This role requires strong U.S., EU, China, and international experience to support our worldwide growth. 

Your responsibilities will include: 

• Review and sign off on product design control documentation to ensure regulatory compliance. 

• Provide technical and regulatory guidance to cross-functional teams throughout new product development and design changes, coordinating inputs for regulatory submissions. 

• Write and review documents for establishing and maintaining EU MDR Technical Files, including preparation for Notified Body submissions and updates due to product or regulatory changes. 

• Support the development and review of responses to non-conformances from Regulatory Authorities, including the Notified Body. 

• Act as the legal manufacturer representative, maintaining positive relationships with internal regulatory specialists and external device reviewers through oral and written communications regarding regulatory strategy, pathway development, testing requirements, and document submissions. 

• Communicate new regulatory requirements and their implications to relevant stakeholders, products, and the Quality System. 

• Provide regulatory feedback and guidance as a core member of manufacturing and remediation teams, coordinating team inputs for submissions. 

• Work with Israeli MOH/AMAR on new product registrations and updates to current registrations. 

• Assist in developing and implementing regulatory strategies for new and modified medical devices. 

• Prepare and submit global regulatory applications and internal regulatory file documentation for new product registrations, renewals, and remediation. 

• Support and participate in audits by presenting regulatory materials and responding to regulatory inquiries. 

• Promote a work environment of continuous improvement that aligns with BSC’s Quality Policy, Quality System, and applicable regulations. 

Required qualifications: 

• Bachelor’s degree in a scientific, technical, or related field 

• 8+ years of Regulatory Affairs experience in the Medical Device industry 

• Knowledge of FDA, EU, and global medical device regulations for medical devices 

• Experience with product development, design control, and global registration processes 

• Working knowledge of regulatory requirements for capital equipment and invasive disposable devices 

• Effective written and oral communication, technical writing and editing skills in both English & Hebrew  

• Ability to manage several projects  

• Proficiency in Microsoft Office