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Regulatory Affairs Manager

£Negotiable DoE | Yorkshire & The Humber |  Regulatory Affairs, Pharmaceutical Company/Sponsor side |  Permanent  | Ref:887525

The Role

Regulatory Affairs Manager - Medical Devices - £Negotiable, West Yorkshire

 

The Company

This is an exciting time to join an expanding, highly successful medical devices company in West Yorkshire.

  • Excellent career progression opportunities

  • Highly successful medical devices company

  • Great working environment and very competitive salary

 

The Role

The Regulatory Affairs Manager is responsible for;

  • Prepare and compile technical dossiers / documentation for CE and FDA review

  • Create technical files for Class I, IIa and IIb Devices

  • Prepare FDA 510K applications

  • Line manage a small team

 

You

  • Full lifecycle Regulatory Affairs experience within medical devices

  • Understanding of the Medical Device Directive

  • Experience with Class I, IIa, IIb Devices

  • Knowledge of Medical Device Regulation 2017/745/EEC requirements

 

What should you do next?

This Regulatory Affairs Manager job is a great role and won't be around for long! So don't delay. If you are unsure and need some advice, give me a ring, otherwise just click apply, upload your CV and send, it's really that easy!

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there. Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Consultant

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Hayley Shayestehroo

Which team and area do you work/specialise in?

I work in the Regulatory Affairs team and recruit for Regulatory Affairs professionals at all levels within Pharma, Medical Devices companies and Regulatory Consultancies

What are some of the typical roles you cover?

I cover Regulatory Affairs positions at all levels within Pharma, Medical Devices and Regulatory Consultancies, these typically include;

Regulatory Affairs Associate jobs, Regulatory Affairs Executive jobs, Regulatory Affairs Senior Associate jobs, Regulatory Affairs Manager jobs, Regulatory Affairs Senior Manager jobs, Regulatory Affairs Director jobs, Regulatory Affairs Consultant jobs, Regulatory Writer jobs and Medical Writer jobs.

What are the hot issues in your sector currently?

Within Medical Devices it is the transition from MDD to MDR in May 2020. A lot of medical device companies are hiring Regulatory professionals to prepare their company for the transition

What’s makes you #DistinctlyDifferent?

I take pride in getting to know my candidates on a personal level as well as professional. Changing jobs is a big decision for most people so I like to ensure I am placing my candidates in a role that not only matches their career aspirations but also suits their personal situation and key motivations.

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