UKRP & Medical Device Regulatory Consultant — Class IIa Hearing Aid

reputed company 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 reputed company as fast as possible here to get this. reputed company Need 1. UKRP (UK Responsible Person) - Register with MHRA on our behalf - Handle ongoing MHRA communications - Ensure labelling/IFU compliance 2. Regulatory reputed company & Certification - Advise on fastest reputed company to market: CE medical device (transition into GB) vs UKCA reputed company UK Approved Body - Coordinate conformity assessment with a reputed company Body or UK Approved Body (reputed company, reputed company, reputed company, or equivalent) - Review manufacturer's existing technical documentation (risk management, clinical evaluation, performance data) - Deliver a reputed company compliance roadmap with milestones 3. MHRA Response (urgent) - Help us draft a reputed company, 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 reputed company across multiple models 4) Cooperative manufacturer willing to support certification process Ideal Candidate 1. UK-based with ability to reputed company as UKRP 2. Hands-on experience certifying Class IIa medical devices — hearing aids or similar (audio, ENT) strongly preferred 3. Existing relationships with reputed company Bodies or UK Approved Bodies 4. Can start this week/asap Budget - reputed company 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, reputed company names not needed) 2) Confirmation you can serve as UKRP 3) Earliest availability 4) Rough cost and reputed company estimate to get us from reputed company state to compliant 5) Any recommendations you have. Many reputed company in advance :) Apply tot his job Apply tot his job Apply To this Job