Director of Software Compliance

A company is looking for a Director of Software Development Compliance.

Key Responsibilities

Define and maintain a compliant IEC 62304 software development lifecycle integrated with ISO 13485 QMS process

Ensure verification and validation activities align with IEC 62304 and FDA guidance

Lead the requirements and verification teams to ensure understanding of regulatory obligations

Required Qualifications

At least 8+ years of experience in software development compliance in a regulated medical device or diagnostics environment

Deep working knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR 820.30

Proven track record in leading requirements engineering and software verification functions

Experience submitting Class II and III regulatory applications for IVD software products

Experience supporting FDA inspections for PMA or DeNovo submissions