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Quality Assurance / Regulatory Affairs Officer

Hays Specialist Recruitment Limited
Job LocationLondon
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

New consumer product in medical device field, working on regulatory submissions & QA activities for compliance Your new companyMy client is a young business specialising in medical devices and aiming to be the next household name. Progressing from internal research to public marketing, this is the most exciting time to join them. Reporting to the QA / RA Executive, youll be managing your own workload in a fast-paced environment to deliver a new product to market in compliance with regulatory bodies! Your new role

  • Guiding both new products and improvement project teams through consistent and compliant delivery according to Design Control and Risk Management processes;
  • Supporting with regulatory submissions;
  • Supporting clinical investigation submissions to the MHRA and other authorities;
  • Supporting CAPA investigations and administration were applicable;
  • Playing a vital role in preparing for audits by notified bodies and competent authorities;
  • Liaising with and managing appropriate KOLs;
  • Creating and implementing high impact regulatory procedures;
  • Assisting in the approval of regulatory compliant labelling and promotional material.
    • What youll need to succeed
  • Experience in consumer and medical device product design and development;
  • Experience in regulatory submissions to notified bodies and authorities;
  • Experience in creating and maintaining technical files and preparations of reports;
  • Experience ensuring a high level of compliance with IVD, IVDR, ISO 14971, ISO 13485;
  • Proactive/ able to identify, report problems (or potential problems) accurately and working to find creative solutions.
    • What youll get in returnThis role is a perfect fit for someone who wants to join a business at an exciting stage of growth. With a start-up, you can have a genuine impact on taking a new product to market. Offering a competitive salary, bonuses, share scheme options, high number of annual leave days and much more, this company has so much to offer. Contact me to find out the other benefits you could get!What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

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