Regulatory Affairs - Med device consultant

CK Group are recruiting for a Regulatory Affairs Medical Device contractor to join a medical device company at their site based in Farnham, Surrey on a contract basis for 6 months and has an hourly rate of £36 per hour (umbrella).

Company:
This company is a successful medical device company with experience in the UK and European device markets.
Their company goal is to provide leading products to improve treatment for patient that are cost effective for the healthcare provider.

Location:
The office is based in Farnham, Surrey, with easy access from Basingstoke, Guildford, Woking, Winchester via car or approximately 1.5 miles from the station by foot.

Salary:
Hourly £36 per hour (umbrella option)
PAYE via CK also available

Regulatory Affairs Medical Device consultant will:
- provide regulatory advice and expertise in relation to identifying and implementing changes required to the company’s quality management system (QMS) in order to maintain compliance with the regulations of all appropriate authorities. Including creating and reviewing Standard Operating Procedures (SOPs).
- monitor medical device regulatory changes and coordinate/implement appropriate procedural changes within the QMS.
- champion and implement the group’s transition strategy for MDR compliance and to implement it.
- assist in compiling and updating technical files for new medical device product submissions and registrations. orking closely with all third parties in the process. (MDR745/2017)

Your Background:
- Applicants should have at least 5 years’ regulatory affairs experience in EU and US medical devices, preferably involving the MDR745/2017. They should have significant experience of the processes involved in compliance with all the required regulations; including Technical File creation, classification, registration and Notified Body submissions.
- Experience of medicines regulation would also be an advantage but is not essential.
- Knowledge of EU/US Pharmaceutical and Medical Device regulatory procedures and requirements. ISO13485:2016 and EN ISO13485:2016 Medical Devices Directive 93/42/EEC Certification and MDR745/2017.
- Be capable of working under pressure in order to meet tight deadlines, ensuring attention to detail at all times.

Apply:
For more information or to apply for this Regulatory Affairs Medical Device consultant position please contract Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 53358 in all correspondence.