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Regulatory Affairs Assistant in Derbyshire
Derby based, full-time, permanent.
To assist the Head of Regulatory Affairs in ensuring that the appropriate licensing, marketing and legal compliance of a range of medical devices and systems either manufactured or distributed by our client in order to control their safety and efficacy.
- Compile Technical File/Documentation for class I and class IIa/IIb products in accordance with the MDR 2017/745 requirements.
- Product registration activities with EUDAMED and MHRA
- Assist in compiling Design History File (DHF) and update product risk management files in accordance with ISO 14971.
- Assist in the planning, preparation and submission of regulatory agency applications, reports, or correspondence.
- Assist in the companies’ post market, vigilance and recall activities in accordance with MDR 2017/745 and MDCG guidance. Vigilance and complaint reporting to regulatory authorities.
- Review and approve labelling in accordance with General Safety and Performance (GSPR) requirements
- Update Clinical Evaluation Report in accordance with MDR/MDCG guidance.
- Assist in providing responses to regulatory agencies regarding product information or issues.
- Assist with staff training in regulatory policies or procedures.
- Assist with audits, regulatory agency inspections, or product recalls.
- Compile regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards, including reviewing materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Maintain effective communication and working relationships between Reg. Affairs and other departments.
- Completion of customer regulatory affairs questionnaires.
Experience, Qualifications and Role Specific Skills
- Degree qualification (or equivalent experience in Regulatory Affairs)
- 2+ Years experience in Regulatory Affairs
- Technical File/Technical Documentation creation
- MDD or MDR experience
- ISO 13485:2016 experience
- Medical device industry experience
- Knowledge and experience in Design History File
- Technically astute
- LEAN manufacturing experience (desirable)