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Regulatory Affairs Specialist II

1 month ago

Santa Clarita, California, United States Boston Scientific Full time

About the Position:
As a Regulatory Affairs Specialist II at Boston Scientific, you will play a crucial role in ensuring the company's products meet regulatory requirements worldwide. This is a hybrid position that requires minimum three days of office work per week, with a preferred location in Valencia, CA, and flexibility to be located in other US BSC locations.

Key Responsibilities:

  • Support the preparation of submissions for obtaining various worldwide approvals to commercially distribute products.
  • Collaborate with Clinical Research to prepare applications for conducting clinical investigations in the U.S., Canada, Australia, and EU countries.
  • Prepare required submissions to facilitate the continuation of clinical studies.
  • Participate in review and submission activities to maintain marketing approvals.
  • Support product registrations for international markets as needed.
  • Contribute to project development teams and review plans, reports, and risk management associated with product and process projects.

Requirements:

  • A minimum of a bachelor's degree and 1-3 years of 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.
  • Ability to work in fast-paced cross-functional teams.
  • RA certification (by Regulatory Affairs Professional Society).