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Regulatory Affairs Specialist

Permanent or temporary - - Quality Management in Pharma & Life Sciences

Regulatory Affairs

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  • Regulatory expertise
  • MDR knowledge
  • ISO 13485

What you'll do

Regulatory Affairs Specialist

As a Regulatory Affairs Specialist, you'll ensure the appropriate licensing, marketing and legal compliance of a range of intervention Medical Devices.

  • Ensure that a company's products comply with the regulations of the regions where they want to distribute them
  • Keep up to date with national and international legislation, guidelines and customer practices
  • Collect, collate and evaluate scientific data from a range of sources
  • Develop and write clear arguments and explanations for new product licences and licence renewals
  • Prepare submissions of licence variations and renewals to strict deadlines
  • Liaise with, and make presentations to, regulatory authorities

Who we're looking for

Education and experience - desirable

  • Minimum 2 years’ experience gained within a regulated healthcare industry
  • Knowledge of the Medical Device Regulation 
  • Degree in a scientific discipline
  • Regulatory affairs experience in a medical device/IVD regulated industry
  • Great spoken and written English.

What you'll get

Our Pharma & Life Sciences department is growing. We offer you the opportunity to join our dynamic team of consultants, work on projects that will challenge you, and that will push you towards the next step of your career.

Do you have what it takes? Apply now.

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