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Regulatory Affairs Engineer

Reference Number: 923183 | Location: United Kingdom | Division: Scientific Permanent

Regulatory Affairs Engineer
Medical Devices- West Sussex

£40,000 - £60,000 + Benefits

The company


Our client is an innovative provider of critical care solutions and their products are available worldwide. They provide excellent customer service and have a commitment to improving the quality of life of patients.


The opportunity


This is a fantastic opportunity to further your career with a global supplier of healthcare technology. Reporting to the Head of Quality Assurance and Regulatory Affairs, you will ensure that regulatory requirements are met for new product introduction and design changes to established products.



Essential skills


  • Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences;
  • 3 years regulatory experience gained within the medical device, health or in vitro diagnostic sector;
  • Experience of ISO 13485;
  • Knowledge of ISO14971, BS EN 60601, IEC 62366 and IEC 62304;
  • Organised in terms of prioritising workload and regulatory filings;
  • Knowledge of risk management and design validation approaches. Understanding of type testing relating to software medical devices, electrical safety and other directives applicable to software medical devices.


Desirable skills


  •  3-5 years in Medical Device related industry or in vitro diagnostic sector;
  •  Experience with regulatory agencies (such as FDA, MHRA);
  •  Experience with Project Management;
  •  Experienced interaction with regulatory agencies;
  •  Good awareness of FDA 21 CFR part 820 Quality System Regulation.





Harris Lord is acting as a recruitment agent for this role.


Contact: Adrian Hole

Keywords: FDA, MHRA, regulatory, 13485, audit, medical device, audit, life science, 14971, 60601, 62366, 62304

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