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Regulatory Affairs Specialist

£negotiable | South East, Buckinghamshire |  Regulatory Affairs, Pharmaceutical Company/Sponsor side |  Permanent  | Ref:889584

The Role

Regulatory Affairs Specialist - Global Medical Devices Company - High Wycombe - £negotiable

Regulatory Affairs Specialist is responsible for the day to day management and co-ordination of the technical documentation for Medical Device files and creation of such files as per requirements of regulations and ISO13485.

The Company

This is an exciting time to join an expanding, highly successful global medical devices company based at their site in Buckinghamshire. They are a privately owned company who have great career development and training opportunities.
  • Global, leading medical devices company
  • Privately owned
  • Market and distribute a range of high-qualitydevices

The Role

The Regulatory Affairs Specialist will be responsible for;
  • To undertake the day to day management and co-ordination of the technical documentation for Medical Device files and creation of such files as per requirements of regulations and ISO13485
  • Supporting the Quality Management Systems within the business ensuring compliance to ISO 13485, Medical Devices Regulations and other ISO standards.
  • Work closely with Senior Management to develop and deliver a range of proactive and responsive processes to maintain compliance.

You

To apply for this role as a Regulatory Affairs Specialist our client is hoping for someone with the following skills and experience;
  • Good regulatory experience within medical devices
  • Good knowledge of MDD/MDR
  • Good knowledge of ISO 134585
  • Excellent stakeholder management experience
  • Excellent project management experience

What should you do next?

This Regulatory Affairs Specialist role is one not to be missed; it encompasses the opportunity to work with new and exciting products within a company who are at the forefront of medical devices. To discuss further, please submit your current CV. 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 is your greatest fear?

I don’t really have one, but if there’s one thing I’m well not keen for it would be snakes or an army of ants…

 

How would your friends describe you in three words?

Funny, healthy, sporty

 

You’re stranded on a desert island – what one thing could you not live without?

Bear Grylls! He’d have us rescued in no time!

 

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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