Regulatory Quality Support (9 Month FTC)

Location: Gloucester, Gloucestershire
Job Type: Contract
Salary: Up to £25000.00 per annum
Reference: BBBH1255_1582623382
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Gap professional are operating as an employment agency on behalf of its client, who are looking for a Regulatory Quality Assistant

Job Type: 9 month (FTC), potential to be extended
Location: Quedgeley
Hours of work: Monday - Friday 9am - 5pm
Salary: £25,000


To ensure business compliance to legislation and quality standards in support of the company's overall goals for the delivery of cost effective, high quality products and excellent customer service.

Key Responsibilities:

  • Ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC and ISO14971)
  • Assist with product correction actions (recalls, corrections & removal)
  • Assist in the issuance of advisory notices as required, in accordance to the MDD and FDA regulatory requirements (21 CFR 803)
  • Maintain systematic records and comprehensive documentation of vigilance and complaint handling activities and applicable correspondence
  • Collate, update and maintain product registration information (including Product Technical Files, Quality/Technical Agreements, 510(k) files and DMR's)
  • Assist with CAPA and PMS activities as required
  • Participate in risk management activities pursuant to the ISO14971 Std, ref plans, FMEA's and reports
  • Assist in the product registration process as relevant to network of customers
  • Respond to customer requests concerning technical documentation and questionnaires
  • Liaise with external parties (Notified Bodies, Competent Authorities, FDA etc) on matters relating to the Quality Management System

Candidate Attributes:

  • At least 5+ years working in a regulatory type role
  • Experience and knowledge of the MDD 93/42/EEC (as amended by 2007/47/EC) and familiarity/understanding with the MDR 2017/745
  • Knowledge of relevant legislation and regulations relating to medical devices and regulatory procedures in the UK, EU, US and Canada
  • Experience of direct interactions with Notified Bodies and National Competent Authorities
  • Experience with regulatory submissions and compliance to CE marking requirements
  • Knowledge of ISO13485 quality management systems and the medical device single audit programme (MDSAP)
  • Knowledge of the ISO14971 Std and risk management activities

Closing date is 25th March 2020

To Apply please follow the application process for the site this job is advertised on or email your CV to. By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. To view our full Privacy Policy please visit our website.
Gap professional are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future.