Regulatory Affairs Specialist II

4 weeks ago


Santa Clarita, California, United States Boston Scientific Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Boston Scientific. As a key member of our regulatory team, you will play a critical role in supporting the preparation of submissions to obtain various worldwide approvals for commercially distributing products.

Key Responsibilities
  • Support the preparation of submissions (e.g., PMA, PMA supplements, CE marking applications) to obtain various worldwide approvals to commercially distribute products
  • In conjunction with Clinical Research, support the preparation of applications (e.g., 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
Requirements
  • A minimum of a bachelor's degree and 1-3 years' work experience in regulatory affairs
  • Prior experience with class III Medical Devices
  • Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards
Preferred Qualifications
  • Effective written and oral communication, technical writing, and editing skills
  • Interpersonal, communication, and negotiating skills
  • Works well in fast-paced cross-functional team environments
  • RA certification (by Regulatory Affairs Professional Society)

This is a hybrid position (in office minimum three days per week) with a preferred location in Valencia, CA, with flexibility to be located in other US BSC locations. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Boston Scientific is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive workplace that reflects the diversity of our patients, customers, and communities.



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