Senior Regulatory Affairs Specialist

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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.The Senior Regulatory Affairs Specialist is responsible for regulatory affairs support of submissions and on going regulatory compliance for product development & design changes processesMain Duties:Provide Regulatory read on product design and process changes to cross- functional teamsReview and signs-off on product design control documentation for compliance with applicable regulationsActs as a core member on manufacturing and remediation teams, providing regulatory feedback and guidance throughout the program, and coordinating team inputs for submissionsComplete Regulatory assessment forms and work with the international team on understanding the global implications of the changesWork on the writing and review of documents to establish EU MDR Technical Files, in preparation for submission to the Notified BodyUnderstand implications of new regulatory requirements and cascade them to all relevant stakeholders, products and Quality SystemResponsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentationSupport Product development projects from Regulatory perspective – establish regulatory deliverables and accompany a project team throughout the projectSupport documentation legalization that is needed for international submissions (notarization and apostil)Support with FSC issuing and updateWork with Israeli MOH/ AMAR on new product registrations and update to current registrationsTechnical files – establishment for new products, maintenance of current Tech Files with changes to products and changes to Regulations, issuance of TF yearly review reportPartner with the Regulatory Integration team on different regulatory tasksSupport audits (both external & internal) presenting Regulatory materials and with Regulatory inquiriesSupport a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they supportActs 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 reviewManage distribution controls for products per regulatory requirements and clearancesRequired Qualifications:Bachelor’s degree, preferably in a scientific or technical disciplineAt least 6 years Regulatory Affairs experience in the medical device industry (FDA, CE, International Regulations)Working knowledge of design control documentation/requirements requiredExcellent written & verbal EnglishPrevious experience working with different PLM & ERP systems, Microsoft OfficeEffective research and analytical skillsRequisition ID: 624377As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!