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.
• 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
• 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
Please contact Nathan Berkley on 0203 019 6020 or email email@example.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.
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Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/