Boston Scientific Senior Regulatory Affairs Specialist 

Israel, North District, Yokneam Ilit 

199928154

Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development & changes support of both design and processes.

Main Duties:

• Provide Regulatory read on product design and process changes to cross- functional teams
• Act as a core member on manufacturing and remediation teams, providing regulatory feedback and guidance throughout the program, and coordinating team inputs for submissions
• Complete Regulatory assessment forms and work with the international team on understanding the global implications of design and process changes
• Coordinate submission activities including, but not limited to: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings
• Work on the writing and review of documents to establish EU MDR Technical Documentation, also in preparation for submission to the Notified Body
• Understand implications of new regulatory requirements and cascade them to all relevant stakeholders, products and Quality System
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation
• Support Product development projects from Regulatory perspective – establish regulatory deliverables, accompany a project team throughout the project and review and sign- off on product design control documentation for compliance with applicable regulations
• Support documentation legalization that is needed for international submissions (notarization and apostil)
• Support with FSC issuing and update
• Work with Israeli MOH/ AMAR on new product registrations and update to current registrations
• Maintenance of current MDD Tech Files with changes to products and changes to Regulations
• Partner with the Regulatory Integration team on different regulatory tasks
• Support audits (both external & internal) presenting Regulatory materials and with Regulatory inquiries
• Support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support
• 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

Required Qualifications:

• Bachelor’s degree, preferably in a scientific or technical discipline
• At least 8 years' experience in the medical device industry (FDA, CE, International Regulations); if in Regulatory – 6 years
• Working knowledge of design control documentation/requirements required
• Excellent written & verbal English
• Previous experience working with different PLM & ERP systems, Microsoft Office
• Effective research and analytical skills