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.
1. 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.
2. Assist in generation of required submissions (progress reports, etc.) to facilitate the continuation of clinical studies.
3. Assist in generation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products.
4 . Participate in the subsequent review and submission activities (annual reports, change notifications, etc.) to facilitate the maintenance of marketing approvals.
5 . Obtain product registrations for international markets as required.
6. Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
7. Other duties as assigned.
-BS in scientific discipline/engineering required.
-4+ years of experience in the area of worldwide regulatory affairs (both submissions and compliance) at medical device companies.
Knowledge of U.S. FDA, Canada and EU regulations and standards.
-Interpersonal, communication and negotiating skills.
-RA certification (by Regulatory Affairs Professional Society)
Boston Scientific Corporation - 8 months ago
Boston Scientific knows that nothing is simple in matters of the heart. The company makes medical supplies and devices used to diagnose and...