Regulatory and Quality Manager - Medical Devices (ISO13485/MDR)

Regulatory and Quality Manager - Medical Devices (ISO13485/MDR)

Permanent Opportunity

ASAP START (Jan/Feb 2025)

KEY ACCOUNTABILITIES:

• Ensuring the declaration of conformity and technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure
• Providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
• Ensuring personal and company compliance with local regulations, policies and procedures
• Product registration in the MHRA database to assure regulatory preconditions for continuous availability of our products on the market
• Liaise with counterparts in Headquarter on all registration application issues
• Active participation in company management meetings, internal processes and development
• Reporting Key metrics to the management team
• Forwarding requests made by the MHRA for samples to the manufacturer to ensure that the MHRA has samples or has been given access to the device
• Cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
• Informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents relating to a device for which they have been designated
• Terminating legal relationship with the manufacturer if they act contrary to its obligations under these Regulations and inform the MHRA and the relevant notified body of that termination
• Responsibility for maintaining and improving the ISO 13485 certified Quality Management System.
• Participation in and conducting internal, 2nd and 3rd party audits.
• Training and onboarding administration

SKILLS/EXPERIENCE REQUIRED:

• The ideal candidate will be educated to degree level (or equivalent), preferably in a Science or Engineering discipline, and will bring previous experience of working within Regulatory Affairs in the Medical Device or IVD field.
• We are looking for candidates with a strong working knowledge of UK & EU MDR Directives, (90/385/EEC and/or 93/42/EEC and/or 98/79/EC), knowledge and understanding of the EU Medical Devices Regulations, (Regulation (EU) 2017/745 and 2017/746) and experience working within an ISO 13485 certified Quality System.
• Experience of working with regulatory frameworks outside the EU is desirable, but not essential.
• Good understanding of global regulatory requirements
• 2-3 years’ experience within the Medical Devices industry (on top of your other industry experience)
• Good working knowledge of Word and Excel
• Good command of spoken and written English
• Attention to detail

If you have not heard back from Projectus Consulting within 7 days please assume your application has been unsuccessful on this occasion only