Medical Device Regulatory Coordinator

hace 1 semana


San José, San José, Costa Rica Smith+Nephew A tiempo completo

Job Title: Regulatory Affairs Specialist II

Reports to: Regulatory Affairs Manager

Location: [Insert Location]

Job Type: Full-time

About the Role

This exciting opportunity is part of our Regulatory Affairs team, responsible for ensuring the company's compliance with regulatory requirements for its medical devices. As a Regulatory Affairs Specialist II, you will play a key role in developing and implementing regulatory strategies, preparing international dossiers, and collaborating with cross-functional teams.

Main Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with US and global regulatory requirements.
  • Prepare international dossiers for EU and global market affiliates.
  • Collaborate with cross-functional teams to deliver high-quality regulatory submissions.
  • Provide expert advice on regulatory matters to internal stakeholders.

Requirements:

  • Bachelor's degree in Engineering, Biomedical Science, Pharmacy, Medicine, or a related field.
  • 2+ years of experience in the Regulatory Affairs medical device industry.
  • Excellent research and analytical skills, with attention to detail.


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