Regulatory Affairs Consultant (Freelance)

Key Responsibilities

• Define and implement US regulatory strategy to support FDA approval of a Class III device undergoing clinical investigation.
• Author, review, and maintain technical and regulatory documentation, including IDE submissions, PMA modules, clinical/regulatory reports, and supporting dossiers.
• Provide hands-on regulatory leadership across clinical and development phases, ensuring alignment with FDA requirements and global regulations.
• Act as SME on FDA regulatory pathways for Class III devices, including clinical, pre-market, and post-approval requirements.
• Collaborate cross-functionally with Clinical, R&D, and Quality teams to ensure regulatory compliance throughout the clinical trial lifecycle.
• Interface with the FDA and other regulatory bodies, including preparation of briefing packages, responses to deficiency letters, and meeting support.
• Support audits and inspections (FDA, ISO 13485), including readiness activities and remediation.
• Ensure compliance with applicable standards and regulations, including FDA QSR/21 CFR Part 820, ISO 13485, and EU MDR where relevant.
• Contribute to QMS processes, including risk management, change control, and clinical/regulatory inputs to post-market planning.

Requirements

• Degree in Life Sciences, Engineering, or a related discipline.
• Proven regulatory affairs experience with Class III medical devices, including US FDA submissions (IDE/PMA).
• Strong expertise in FDA regulatory frameworks, clinical trial submissions, and approval pathways.
• Experience supporting devices in clinical development phases is essential.
• Demonstrated experience interacting with FDA (e.g. pre-submissions, meetings, deficiency responses).
• Knowledge of ISO 13485 and EU MDR is beneficial.
• Ability to operate autonomously in a freelance capacity within cross-functional, fast-paced environments.