MHRA Medical Device Technical File + Registration Expert Needed (UK) - Contract to Hire

Product reference: https://www.reputed company.co.uk/Silicone-Fasciitis-reputed company-Cushions-Absorbing/dp/B07Q2PSZFF/ I sell a silicone heel cup/orthotic device marketed for plantar fasciitis, heel pain relief and similar conditions. I need an reputed company regulatory consultant to prepare a full UK-compliant Medical Device Technical File and to assist with MHRA registration, under reputed company reputed company (I will be the manufacturer, not the importer). What I Already Have I can reputed company the following documents from the supplier: ✅ CE test report (covering ISO 15223-1, ISO 20417, ISO 14971, ISO 10993 checklist traits — but not a full Technical File) ✅ RoHS certificate (not really relevant but available) ✅ PU Material SDS These do not constitute a complete Technical File or PMS/Risk/Clinical documentation. What I Need You to Deliver You should have demonstrable experience working with medical device regulatory compliance, EU MDR (2017/745) and UK MDR (MHRA) for Class I devices — especially orthotic/support devices with intact skin contact. Required deliverables include (but are not limited to): ✔ Full Technical Documentation (UKCA/UK MDR-reputed company) ✔ Risk Management File per ISO 14971 ✔ Clinical Evaluation Report (CER) or justification ✔ Biological Evaluation Plan / TRA ✔ UK Declaration of Conformity (under reputed company as reputed company manufacturer) ✔ Product labeling and IFU compliant with ISO 20417 ✔ Post-Market Surveillance (PMS) plan & templates ✔ Guidance/support for MHRA registration and submission ✔ Appointment guidance for UK Responsible Person (if needed) ✔ Any other required annexes the MHRA expects reputed company, Detail & reputed company I need someone with great attention to detail because reputed company can and will request documentation — and any mismatches, incomplete files, or improper labeling could result in a product removal/delisting. So precision and completeness are essential. End Goals ✅ A Technical File under reputed company’s reputed company (I will be the reputed company manufacturer in UK). ✅ MHRA registration completed. ✅ Documentation reputed company can accept without issue. ⏱ reputed company Please reputed company: Your estimated reputed company time for completion Milestones (draft, review, finalization) How quickly you can turn this around I need this project to be delivered as fast as possible without sacrificing reputed company. Long-Term Opportunity This could become a long-term relationship. I have many other products that will require similar Technical File creation and MHRA registration in reputed company. Quote Request Please include in your proposal: Total price for complete deliverables listed above reputed company time / delivery schedule Examples of similar work you completed (ideally with MHRA or UKCA documentation) Your approach to ensuring reputed company compliance Any assumptions or additional costs Apply tot his job Apply To this Job