The company are a niche IVD medical device manufacturer who sell their products not just in the EU, but all over the world. They have seen significant growth year on year and aren’t looking to stop now. The global trend towards specific IVD regulation, a recent update to EU regulation and a company strategy to move into the US have led to increased demand on regulatory resources.
Regulatory Affairs Specialist, £40-45k, Cambridgeshire, Medical Devices, IVDs
• Regulatory registration and submissions
• Co-ordination of performance evaluations and validations
• Maintaining company’s technical files
• Risk Assessments
Tasks and Accountabilities:
• Requirements for regulatory submissions
• Collation of technical file documentation such as risk assessment summaries and product specifications
• Liaising with product managers to ensure timely completion of data analysis for performance evaluation studies
• Liaising with distributors to assist with registrations and any necessary paperwork to facilitate importing company’s products.
• Legalisation of documents
• Coordination of detailed risk assessments
• Carrying out regulatory reviews of quality system documentation and marketing materials as required
• A background in a science related subject as well as experience of working in a regulated medical device or IVD environment.
• Experience of working to ISO 13485 and CFR 820 quality systems would be an advantage.
• The candidate should also have experience of technical file documentation and risk management.
• Experience with documentation for regulatory submission such as for FDA or CE marking is highly desirable.
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 email@example.com to discuss in confidence.
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