Regulatory Affairs Specialist

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities :

Execute post-market surveillance activities and maintain compliance for SaMD products

Prepare and coordinate regulatory submissions for FDA, CE Mark, and other global approvals

Conduct regulatory assessments for new products and changes to existing devices

Requirements :

3+ years of regulatory affairs experience with medical devices, preferably SaMD

Experience with quality standards : 21 CFR Part 820, ISO 13485 : 2016, and MDSAP

Global product submissions experience

Familiarity with AI / ML-enabled medical devices and their regulatory considerations

Experience in regulated software development environments