Regulatory Affairs Manager (IVD)

Hi, I am managing this position

Jess Frost

Consultant

Cheshire
Permanent
£50k - 70k per year
Science

I have an exciting opportunity for a regulatory affairs professional to join a medical device/IVD company in Cheshire, on a permanent basis.

Regulatory Affairs Manager role:

You will be involved in a range of responsibilities, including:

  • Manage and lead the IVDR planning transition for the business.
  • Maintain a high level of specialist knowledge of the regulatory requirements within each of operational geographical territories
  • Managing a small RA team covering all areas of regulatory support for the business
  • Lead the creation, management and maintenance of Technical Files / Medical Device Files for the company’s product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities.
  • Lead and support the preparation of regulatory dossiers to support product license applications, import license applications and maintenance of the same for worldwide Regulatory Authorities.
  • Proactively manage relationships and communications with regulatory agencies and authorised representatives.

Requirements:

  • Working knowledge of 13485, 21 CFR 820/GMP & IVD/IVDD
  • Minimum 2 years’ managerial experience

Why Should You Apply?

This is an exciting opportunity for a regulatory professional that is looking to progress their career with a highly rewarding company offering between £50,000 – £70,000 per annum.

if you are interested do not hesitate in applying to j.frost@x4lifesciences.co.uk  at X4 Life Sciences and call on 020 7812 7700 to discuss further.

About Me:

If this role isn’t what you’re looking for don’t worry, I have over 2 years 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.

Apply

Apply For This Job

Upload your CV/resume or any other relevant file. Max. file size: 2 MB.
I consent to storing and processing my personal data as outlined on the 'How X4 Life Sciences manages and uses your personal data' page.