Regulatory Affairs Specialist II

hace 1 semana

San Francisco, Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

About Boston Scientific

Boston Scientific is a leading medical device company that is committed to improving patient health and advancing science for life. We are seeking a highly skilled Regulatory Affairs Specialist II to join our team in Heredia, H, CR.

Job Summary

This role will be responsible for working on Boston Scientific's recently acquired novel Atrial Fibrillation technology, Pulsed Field Ablation (PFA) (FARAPULSE, Inc.). The FARAPULSE PFA System is the first PFA technology that received a CE Mark in Europe. PFA technology has the potential to alter the future of ablation therapy on a global scale as we expand the reach of this product into other geographies and with different indications.

Responsibilities

  • Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
  • Review of technical documents, and product literature and labeling
  • Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
  • Support regulatory audits, as required
  • Support development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
  • Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
  • Develop and maintain positive relationships with regulatory body reviewers

Requirements

  • Minimum of a Bachelor's Degree
  • Minimum of 3 years regulatory affairs or related experience
  • Working knowledge of relevant US/EU regulatory requirements for medical devices including Quality Systems standards
  • Effective written and oral communication, technical writing and editing skills
  • Works well in fast-paced cross-functional team environments
  • Preferred qualifications: Previous experience with Class II or III medical devices submissions

Why Join Boston Scientific?

Boston Scientific is a company that is passionate about innovation and committed to making a difference in people's lives. We offer a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world.

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