Regulatory Specialist – Medical Devices

The Quality and Regulatory team at DB Orthodontics Ltd, are looking for a Fulltime/Permanent Regulatory Specialist to support the business in all duties necessary for us to remain in compliance with ISO 13485, Medical Device Directive 93/42/EEC and Regulation (EU) 2017/745 (EU MDR).

As a Regulatory Specialist, your primary responsibilities will include:

  • Reviewing, updating and creating technical files and completing Post Market Surveillance activities covering a range of medical devices.
  • Responding to internal and external regulatory queries.
  • Completing Internal Audits.
  • Provide support to the Regulatory Manager and Quality and Regulatory Consultant.

As the Regulatory Specialist, you will need to have the following experience and Skills:

  • Regulatory Affairs experience within medical devices; preferably from a commercial environment (2 – 5 years minimum).
  • Good knowledge of MDD and MDR.
  • Good Knowledge of ISO 13485.
  • Analytical and problem solving skills.
  • Written and oral communications skills with a high level of attention to detail.
  • Ability to multitask and prioritise.
  • Integrity and a professional approach to work.

A technical background would be an advantage.

If you wish to be considered for this exciting opportunity within a progressive and growing business, please apply today by email to Human Resources directly at with an introduction letter and CV, and we will issue you thereafter with the job application form for completion.

Position Sought:       Regulatory Specialist - Medical Devices

Location:                    Silsden, Keighley, BD20

Employment Type:     Full time, permanent

Contracted Hours:    Monday to Friday working a 37.5 hours week

Date:                           April 19th 2024

Closing Date:             May 31st 2024