Regulatory Affairs Manager

Location: Remote
Compensation: To Be Discussed
Staff Reviewed: Fri, Oct 25, 2024
This job expires in: 22 days

Job Summary

A company is looking for a Regulatory Affairs Manager to oversee regulatory initiatives for implant and prosthetic solutions.

Key Responsibilities:
  • Develop and implement regulatory strategies for global medical device clearances and approvals
  • Manage regulatory submissions and communications with FDA and EU notified bodies
  • Provide regulatory guidance to cross-functional teams throughout the product lifecycle

Required Qualifications:
  • Bachelor's degree in life sciences, regulatory affairs, or a related discipline
  • 5+ years of experience in regulatory affairs, preferably in the medical device industry
  • In-depth knowledge of FDA and international regulations (e.g., EN ISO 13485, EU MDR)
  • Regulatory Certification (such as RAC) or a Master's degree in a scientific discipline is a plus
  • Proficiency with regulatory software and Microsoft Office Suite

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