Director of Regulatory Affairs

Job Summary

A company is looking for a Director Regulatory Affairs & Quality Management Contractor.

Key Responsibilities

• Lead and mentor a regulatory and quality affairs team, ensuring compliance and alignment with organizational goals
• Develop and implement regulatory strategies for compliance with FDA, MDR, and global requirements for medical devices
• Coordinate with regulatory authorities and oversee the preparation and submission of regulatory documents for timely approvals

Required Qualifications

• Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs, quality management)
• 10+ years of regulatory affairs experience in the medical device industry, particularly with FDA and Software as a Medical Device (SaMD)
• Knowledge of 21 CFR, ISO 13485, and ISO 27001
• Experience in IT, software development, and/or cloud hosting is preferred
• Training in quality management and quality improvement processes