RA Officer

Job Ref: J25291
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 13 February 2018
  • Essex, England, UK
  • £20,000 - £30,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Graduate Regulatory Officer - Medical Device - EssexSRG are currently recruiting for a Graduate Regulatory Officer to join a SME Medical Device company in Essex on a permanent basis at a salary of circa £20,000 - £30,000 per annum, depending on experience.You will be responsible for supporting the Regulatory Affairs manage to ensure continued compliance for the companys processes and products.Key Tasks will include: · Assist in compliance activities such as customer complaint investigations conducted in accordance with 21 CFR 820.198 and ISO 13485.· Conduct product failure investigations and complete technical report for complaints under guidance of Regulatory Manager within strict timeline.· Review relevant technical information regarding product material and manufacturing processes in line with ASTM/ISO and other relevant standards for product investigations.· Complete administrative activities regarding maintaining complaint files.· Complete administrative activities related to maintaining compliant regulatory status for currently marketed products. Be key member in review and update of the Master Device Schedule (company database for all products and corresponding regulatory information)· Participate in determining reportable events/incidents as per regulatory guidelines in EU, US and Australia in line with current SOP of the company. Conduct reporting activities to regulatory authorities via electronic reporting systems for FDA (eMDR), TGA (EBS), MHRA under guidance of Regulatory Manager within strict timeline.· Participate in data analysis activities for reportable events, recalls and market actions.· Conduct periodic trend analysis of complaints/compliance data as input to Post Market Surveillance.· Participate in maintenance of technical and design history files, review and approval of labelling and promotional materials and regulatory assessment of changes.To be suitable for this role, you will have:· 2:1 or higher in a relevant scientific or engineering discipline.· Analytical mindset required to be able to conduct effective product failure investigation.· Must be good with data processing and simple statistical analysis (VLookup, Pivot Table, IF function)· Exceptional organisational skills.· The ability to present technical, product and regulatory information clearly and concisely.· Good attention to detail.· Must be extremely organised in order to prioritise multiple tasks and execute them within the time.For more information, please call Laith Mustafa on 0161 868 2231 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.