Regulatory Specialist

1 month ago

Lee Hampshire, United Kingdom Dblabsupplies Full time

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 humanresources@dbortho.com 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

Employment Type: Full time, permanent

Contracted Hours: Monday to Friday working a 37.5 hours week

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