Job Description
QUALITY AND REGULATORY MANAGER – MEDICAL DEVICES
Permanent
ASAP Start
Epson area, Surrey. Hybrid working.
Ever wanted to be part of a management team but actually achieve something?
How about moving from big Corporate to a rapidly growing SME in the Medical Devices space.
Most importantly – are you passionate about quality & continuous improvement?
Then look no further!!!
You will need to be someone who balances the Quality duties (i.e. Quality re-writes and auditing) with Regulatory (documentation/process) duties for your company.
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