Product Design Control Specialist

A company is looking for a Product Design Control Specialist.

Key Responsibilities

Liaise between Product and Regulatory teams for all product DHF deliverables

Drive timelines for product deliverables, ensuring timely release and / or submission

Create and maintain project-specific technical file deliverable lists aligned with internal SOPs

Required Qualifications

5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience

3+ years in a regulatory project management or technical role

Experience working in a regulated agile development environment

Familiarity with global medical device regulations : QSR / QMSR, MDD / CMDR / MDR

Experience with eQMS and ALM systems, including enacting QMS requirements