Regulatory Affairs Principal, CA

Job Summary

A company is looking for a Regulatory Affairs Principal, IVD.

Key Responsibilities

• Prepare and manage regulatory submissions for US and EU IVDR and WHO PQ
• Communicate with regulatory agencies and health authorities for product approvals
• Gather and interpret new regulations and guidelines affecting US and EU markets

Required Qualifications

• Bachelor's degree with 8+ years of relevant experience, or Master's degree with 6+ years, or Doctoral degree with 3+ years
• Experience serving as RA lead on NPD core teams for complex projects
• Ability to develop comprehensive regulatory strategies for product launches
• Competency in preparing and submitting diverse regulatory documentation