Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist with IVD experience supporting US and Health Canada.

Key Responsibilities:

• Compile technical documents and author local regulatory submissions for FDA and Health Canada
• Provide guidance to product development teams on local product submission requirements
• Review proposed labeling changes for regulatory impact on existing certifications and registrations

Qualifications:

• Bachelor's Degree required, preferably in STEM/Medicine/Life Science; Master's Degree in Regulatory Affairs preferred
• 2+ years of Regulatory Affairs experience with a focus on the IVD industry required