Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities

Create and execute regulatory strategies for post-market activities and design change evaluations

Manage regulatory initiatives and support global regulatory strategies for new product development

Advise business teams on regulatory issues and ensure compliance with IVDR Technical Files

Required Qualifications

Bachelor's Degree with 3+ years of experience in Regulatory Affairs or a Master's Degree with 1+ year of experience

Subject matter expertise in registration and commercialization of in vitro diagnostic medical devices

Experience in the Biotech pharmaceutical industry

Strong Health Canada and EU submission experience preferred