Senior Regulatory Affairs Specialist

Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer and marketer of medical devices.

Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements.

* Prepare submissions(i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products * In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries. * Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies. * Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals. * Support product registrations for international markets as required. * Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects. * Other duties as assigned.

**Basic Qualifications:** - BS in Scientific discipline/engineering required. - 5+ years of experience in the area of worldwide regulatory affairs in Post Marketing Assessment (both submissions and compliance) at medical device industry. - Class III Medical Device experience - Knowledge and experience of U.S. FDA, Canada and EU regulations and standards. **Preferred Qualifications:** - 7+ years of PMA - Interpersonal, communication and negotiating skills. - RA certification (by Regulatory Affairs Professional Society)