Regulatory Affairs Officer Medical Devices

Posted 10 October by X4 Group
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Job title: Regulatory Affairs Officer (Medical Devices)

Exciting opportunity for an experienced Regulator Affairs Officer at a rapidly expanding company based in Newcastle.

The Company:

My client is a medical device manufacturer known for their leading teams where they offer excellent progression. As a smaller company, they are seeking a highly capable Regulatory affairs officer with experience working in an ISO13485 environment, who is able to assist the QA/RA Manager and take on key responsibilities within the department.

Regulatory Affairs Officer Role:

  • Establishes procedures for maintaining compliance with regulatory standards
  • Supports product registrations and pre-market requirements
  • Supports post-market vigilance reporting and any resulting actions
  • Supports the maintenance of Technical Files
  • Supports the maintenance of specific files such as pre-clinical data files, clinical data file, sterilization files
  • Supports in the development and maintenance of the Risk Management File(s)
  • Participates as required in any Notified Body audit and other such inspection

Regulatory Affairs Officer Requirements:

  • Science related Degree
  • Strong ISO13485:2016 working experience
  • Minimum 3 years in regulatory affairs

Why Should You Apply?

This is an exciting opportunity for a Regulatory manager that is looking to progress their career with a highly rewarding company offering between £32,000 - £37,000 per annum.

If you are interested, do not hesitate in applying to  at X4 Life Sciences and call on to discuss further.

About Me:

If this role isn't what you're looking for don't worry, I have over extensive experience matching talent to the brilliant businesses they deserve in the Quality and Regulatory market and I am working with a number of really exciting clients currently. Please apply via the link if you believe you are suited to this position or you can get in touch with me directly and I can run though all my current vacancies within Quality & Regulatory.

You will find me on LinkedIn -  Jessica Frost, X4 Life Sciences

Alternatively, with 10 years’ experience here at X4 Life Sciences we cover all permanent and contract positions, with specialist industry sector teams. You can check out all of our roles on our website and sign up for job alerts so you are the first to know about a new opportunity.

Reference: 39109576

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