We are delighted to be working with one of the UK’s leading healthcare technology companies, with operations in Europe, the United States and APAC.
Due to continued accelerated growth, along with the complex nature of international medical sales, a Regulatory & Compliance Specialist is sought to join the expanding team based near Peterborough.
You will report to the Compliance Manager and will use your knowledge of the regulatory landscape to ensure products are developed, manufactured, and distributed according to required regulations and standards pf each country.
You will have knowledge of European, US and Asian markets, keen awareness of regulatory guidelines and legislation, experience in ensuring compliance with MDR and BPR and excellent working knowledge of BPR, MDR, FDA, CE marking and UKCA frameworks.
An understanding of international standards (ISO 13485 & 14971) is essential along with knowledge of IEC 60601.
As part of your responsibilities, you will maintain product compliance, ensuring products meet regulatory and technical standards. You will prepare data to obtain certifications and commercialisation authorisations along preparing safety data sheets, tracking and reporting on assigned projects and manage relevant technical documentation and files.
Based in Cambridgeshire, this position is commutable from Norfolk, Suffolk, Lincolnshire and Northants, with locations such as Peterborough, Nowich, Cambridge, Corby and Leicester all commutable. They offer some flexible working but due to the nature of the role you would need to be in the office regularly.
Zero Surplus is East Anglia’s premier commercial recruitment specialist, based just outside Cambridge we source compliance and regulatory staff for small and international medical & technology businesses across the UK and East of England.
For registration purposes please could you let us know where you are currently based or which locations you are considering as well as your required salary and notice period.
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