Regulatory Affairs Consultant (Freelance), Brussels

Regulatory Affairs Consultant (Freelance)

Contract:

12 months (extendable) Start:

July 2026 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.

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