Home based Regulatory Affairs Specialist

Job Reference: #60291 Add to saved jobs

  • Location United Kingdom, Home based
  • Permanent
  • Sector Medical Devices

Job Summary

Would you be interested in a permanent, home-based regulatory affairs position? I'm currently recruiting on behalf of a company which is seeking a medical device RA Specialist to join their team; one who has experience with writing technical documentation such as tech files, risk, design dossiers, cer's etc. This company have a unique set-up within the business which is attracting great attention, and I’d be happy to discuss it further with you.

Job Overview

• Involvement in, and maintaining an appropriate and effective regulatory strategy to achieve compliance
• Understand and apply quality assurance procedures in line with ISO 13485:2016 quality management system standards, the Medical Devices Directive 93/42/EEC (as amended) and Medical Device Regulation MDR 2017/745.
• Prepare registration dossiers for approval globally
• Prepare Technical Files for CE approval
• Support Risk Management activities

Skills Required

• Degree in life sciences or engineering
• 3 years’ experience in medical devices, within a regulatory affairs capacity
• Knowledge of EU medical device regulations
• Hands on writing of technical documentation for regulatory approval
• Knowledge of ISO13485 quality management systems
• Ability to work remotely

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

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