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Employers

Work from home, RA Specialist/ Consultant (MDs & IVDs), England

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Location:

England, United Kingdom 

Job Category:

Healthcare

Salary:

€50,000.00 - €65,000.00

EU work permit required:

Yes
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Job Reference:

OK 1685_1622707557

Job Views:

37

Posted:

03.06.2021

Expiry Date:

18.07.2021
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Job Description:

A good client of mine is looking for a Regulatory professional who would be interested in a remote opportunity. It’s also possible to work locally in Warwickshire or travel there occasionally. Perfect if you are looking for some flexibility.

You will be joining a friendly team of RA/ QA professionals who are highly experienced and are happy to offer support so that you can work comfortably on different projects. They are relatively small compared to other companies so tend to have a family culture where you know everyone and are seen in the business. Will suit someone who likes a more personal, warmer environment where your personal qualities are valued as highly as your professionalism.

The role will suit someone quite experienced who would like to add some variety and a new challenge in the career so you will still be able to learn new things in your job and take on more tasks and have more responsibilities.

As part of your role you will be responsible for compilation and review of technical documentation for CE marking. 510k submission to FDA (Class I, IIa, IIb, III) with a strong focus on Clinical Evaluation compilation to current MEDDEV guidance and Risk management implementation to Med Devices standard ISO 14971. You will prepare and approve regulatory files in accordance with UK/ EU and US requirements for medical devices and IVDs.

Please get in touch if you have the below requirements:

* Degree in Life Sciences or relevant certification
* 5+ years RA experience within Medical Devices and IVD
* good experience with ISO 13485, FDA 21 CFR Part 820,MDSAP, ISO 14971
* internal/ supplier auditing experience

Fast and straightforward process, apply now to discuss further!

This is a permanent opportunity so only apply if you are able to work full time.

Please forward your CV in the Word format to Oksana Kolesnichenko or recommend this role to someone who would be suitable: nonstop-recruitment.com

The job market changes very quickly so do not forget to connect with me on Linked in, check other roles that I am hiring for at the moment and follow for any future relevant roles.

NonStop is dedicated to raising the standard of ethical recruitment and comprises a number of brands, each having their own niche sector focus.

Job Requirements:

regulatory affairs specialist medical devices IVD
Company Info
NonStop Consulting
25 Canada Square, Canary Wharf
London, United Kingdom
Phone: +44 0207 234 0550
Web Site: www.nonstopconsulting.com
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