Are you looking for an engaging role, working on a large number of technical files, risk management & CERs for a wide range of medical devices? My client are seeking a self-starting Regulatory Affairs Specialist to hit the ground running with the exciting projects they have. Along with a competitive salary, they also have a strong benefits package including quarterly bonuses!
• To generate and maintain technical files for CE marked medical devices.
• To ensure that all products comply with regulations of the MHRA and other relevant Competent Authorities.
• Advise company of Regulatory changes affecting the Business, Quality Management and medical devices. Implement these changes where necessary.
• Control and keep up to date the Risk Management Files and Clinical Evaluation reports for each Technical file. Maintaining an up to date life cycle of the devices.
• Ensure that all Regulatory requirements are fulfilled for new devices and that these devices are integrated into new or existing Technical files.
• Organise and fulfil regular Post Market Surveillance and product review meetings.
• A comprehensive understanding of ISO9001, ISO13485, MDD, MDR and CE marking of medical devices.
• At least 4 years experience in a QA/RA role relating to medical devices and Technical file compiling.
• Comprehensive understanding and training with ISO14971 Risk Management and MEDDEV 2.7/1 Clinical Evaluation
Full job description and company details are available upon application, apply below. This position is being dealt with by Nathan Berkley at Meet, please call 0203 019 6020. You can also e-mail us directly at firstname.lastname@example.org to discuss in confidence.
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