Regulatory Affairs

5 days ago

Epsom Surrey, United Kingdom PROJECTUS Full time

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

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