We have an opportunity for an organised and enthusiastic Regulatory Engineer to join our Quality & Regulatory team, to help ensure that our products are correctly classified and registered and meet all relevant test and safety standards.


The Role

The Regulatory Engineer will carry out the following tasks:

  • Collaborate with Cyden and customer regulatory teams to determine the global device classifications for new project lines
  • Support the registration activities for new medical device submissions
  • Maintain global regulatory certifications and compliances for existing device lines
  • Develop a detailed knowledge of test and safety standards to comply with the international regulatory marking requirements for international launches
  • Prepare and deliver initial device submission samples to regulatory test bodies for review and evaluation

Full product and regulatory territory training will be provided.

The Person

Essential requirements:

  • HNC/HND Electrical/Electronic Engineering
  • Excellent written and verbal communication skills
  • Excellent accuracy and attention to detail
  • Capable of working on multiple projects, both independently and in a team environment
  • Able to critically evaluate and summarise complex data into simple messages and actions
  • Prepared to build networks and alliances with peers and external partners

Desirable requirements:

  • A degree in a relevant scientific discipline, or equivalent experience
  • Regulatory experience within medical devices
  • Working knowledge of ISO 13485

The successful candidate will be efficient, well organised and have a systematic and methodical approach to their work. They will have a positive and motivated attitude

Salary and Benefits

  • Competitive salary
  • 25 days holiday
  • Pension
  • Childcare Voucher scheme
  • Cycle to Work scheme
  • Free parking

To Apply please send your CV and a cover letter to: cwilliams@cyden.com, quoting ‘Regulatory Engineer’ in the subject line. The closing date for applications is 26th March 2018.