Monarch Recruitment Limited
This job has been posted for more than 30 working days and has expired.

Regulatory Affairs Manager

Regulatory Affairs Manager

My client is an award winning market leader in the manufacture of specialised medical products.

They are seeking a Regulatory Affairs Manager to join their well-established team based in Essex on a contract basis.

This contract is currently gauranteed until September but it is likely that this will be extended. 

As Regulatory Affairs Manager you will be responsible for ensuring continued compliance to all relevant regulatory and quality requirements.

Timely identification to regulatory changes will be essential to ensure that there are no negative impacts on the business as will making sure that all current regulations and standards are available across departments.

You will be responsible for the generation and maintenance of the DMR, Recall files, risk management files & other technical documents relating to compliance.

Another key aspect is the responsibility to support and supply information as required relating to product registration in any market including site registrations including FDA 510(k), CE Marking etc.

Support of change management processes is also important and you will need to report changes as appropriate.

You will also have to contribute to the maintenance of SOPs.

Key Qualifications/Experience required includes:

- University degree in a scientific/engineering subject
- Past experience in a regulatory or quality role at a Medical Device manufacturer
- A good knowledge of ISO 9001, ISO 13485 & FDA regulations


To apply please apply online or call Tanya Zero on 01212373340.

Successful applicants will be contacted within 7 days.