Senior Regulatory Specialist

Location: Remote
Compensation: Salary
Staff Reviewed: Mon, Mar 25, 2024
This job expires in: 5 days

Job Summary

A company is looking for a Senior Regulatory Specialist.

Key Responsibilities:
  • Conduct regulatory research and provide guidance for new product development
  • Author pre-submissions and 510(k)s for US FDA
  • Manage global regulatory approvals and collaborate with external partners

Required Qualifications:
  • 5-7 years of experience in Regulatory Affairs
  • Minimum 3 years of software medical device experience
  • In-depth knowledge of global regulatory requirements
  • Demonstrated collaboration with marketing and clinical for strategic regulatory claims
  • Demonstrated leadership skills

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