Back to search
- Supporting and guiding the design team in the compilation or remediation of supporting documentation to ensure regulatory compliance.
- To lead and author key documents within the technical file.
- Guiding the marketing team in producing regulatory strategy and then executing for global product registrations.
- To author procedures and templates to support the regulatory function.
- Supporting the QA function where appropriate, including CAPA and internal audits.
- Ensuring compliance with EU MDR and UK MDR.
- Supporting with the development of the ISO 13485 QMS.
- Assisting with the strategy development regulations, including all test plans.
- Compiling technical files and remediation.
- Labelling and packaging compliance documents.
- Must have a good understanding of EU/UK Medical Device Regulations (MDR).
- Ability to author and/or lead development of key documents within a technical file, e.g. Clinical Evaluation Report (CER), Risk Management File (RMF), Post Market Clinical Follow Up (PMCF).
- Knowledge of Instructions for Use (IFU), labelling and packaging requirements.
- Experience of leading or contributing to global product registrations.
- Good knowledge of ISO 13485, ISO 14971.
- Excellent communication skills; both internally and externally.
- Familiarity of NHS supply chain quotation/registration process.
- Knowledge of the following IEC standards (60601-1, 60601-1-2, 60601-2-52, 62304, 62366-1)
- Experience with MEDDEV 2.7.1 Clinical evaluation.
- 25 days annual holiday plus bank holidays
- Free parking
- Free tea and coffee
- Company events
- Company pension
