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Regulatory Affairs Specialist - Remote Working

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    Will Godfrey

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    etwa 2 Stunden her

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Austin Vita has a fantastic opportunity for a Permanent QA/RA Consultant with 60601/62304 experience.
The position offers fully remote working and flexible working hours!!!

The position will suit someone with good, broad experience in regulatory affairs within medical devices. You will ideally have a combination of the following skills;

  • Experience within active medical devices (60601/62304)
  • Degree level education or relevant work experience
  • Excellent communication, presentation and influencing skills
  • Experience within active medical devices (60601/62304)
  • Set up of technical documentation & design dossiers
  • Undertaking US FDA 510(k)s, PMAs (Premarket Approvals), IDEs (Investigational Device Exemptions), Pre Submissions and Designations Submission
  • Regulatory submissions - global markets
  • Quality Management Support
  • Solving regulatory questions on classification, technical files, device master records (DMRs). Device history records (DHRs). Design history files (DHFs), process validation, software validation
  • Conduct or advise on design / product risk management activities
  • Reviewing, updating and writing of Clinical Evaluation Reports (CER's)
  • Conduct or advise on post market surveillance and vigilance
  • Support to maintain or expand market access to various markets including EU, USA, UKCA
  • Conduct or advice on validation projects
  • Management of quality systems
  • Compliance with the European Medical Device Regulation (MDR)

You will be rewarded with a great salary and flexible working, with a good level of variety and challenge, whilst being supported in developing further skills and experience for your career growth.

If this sounds of interest, please apply ASAP as my client is currently shortlisting for interview.

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.