Regulatory Affairs Consultant
Key Responsibilities
- Update and rewrite Risk Management documentation to ensure full compliance with EU MDR 2017/745 and ISO 14971.
- Maintain and improve technical documentation, including Risk Management Files (RMFs) for new products and major design updates.
- Support responses to Notified Body queries, nonconformities, and audit preparation.
- Review Qualification & Validation documents in a GMP context (URS, DQ, IQ, OQ, PQ, PV, PPQ, CPV).
- Ensure alignment of validation lifecycle elements (change control, CAPA, deviations, OOS/OOT).
- Update QMS documents (SOPs, WIs, templates) and contribute to continuous improvement.
- Support PMS/PMCF‑driven updates, quality events, and cross‑functional project needs.
- Provide methodological guidance to project and operational teams.
Requirements
- Strong background in Regulatory Affairs, Risk Management, or QA/Validation within pharma or medical devices.
- Solid working knowledge of MDR 2017/745, ISO 14971, and GMP validation practices.
- Experience reviewing technical files, validation documentation, and QMS records.
- Able to work independently and communicate effectively across QA, RA, and project teams.
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