Job Description
About us We're a UK-based DTC brand, selling hearing aids in the UK. Our manufacturer has an ISO 13485 certified and holds UKCA EMC certification, but does not yet have medical device certification (CE under EU MDR 2017/745 or UKCA under UK MDR 2002). We would like to move as fast as possible here to get this. What We Need 1. UKRP (UK Responsible Person) - Register with MHRA on our behalf - Handle ongoing MHRA communications - Ensure labelling/IFU compliance 2. Regulatory Strategy & Certification - Advise on fastest route to market: CE medical device (transition into GB) vs UKCA via UK Approved Body - Coordinate conformity assessment with a Notified Body or UK Approved Body (SGS, TÜV SÜD, BSI, or equivalent) - Review manufacturer's existing technical documentation (risk management, clinical evaluation, performance data) - Deliver a clear compliance roadmap with milestones 3. MHRA Response (urgent) - Help us draft a credible, transparent response to the MHRA What Already Exists 1) ISO 13485 certified manufacturer 2) UKCA EMC certificate and full 32-page test report (BS EN 55032) 3) Product manufactured at scale across multiple models 4) Cooperative manufacturer willing to support certification process Ideal Candidate 1. UK-based with ability to act as UKRP 2. Hands-on experience certifying Class IIa medical devices — hearing aids or similar (audio, ENT) strongly preferred 3. Existing relationships with Notified Bodies or UK Approved Bodies 4. Can start this week/asap Budget - Open to discussion. We expect an annual UKRP retainer combined with a project fee for the certification and MHRA response work. To Apply, please send us over: 1) Specific Class IIa certification experience (examples welcome, client names not needed) 2) Confirmation you can serve as UKRP 3) Earliest availability 4) Rough cost and timeline estimate to get us from current state to compliant 5) Any recommendations you have. Many thanks in advance :) Apply tot his job
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