Regulatory Affairs Specialist - Class III Devices

Location
Copenhagen, Copenhagen Municipality, Denmark
Salary
£5873.47 - £6777.07 per month
Posted
25 Feb 2021
Closes
25 Mar 2021
Ref
AS280611-1
Contact
Anders Sandberg
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

I am currently working with a client based in Denmark who are searching for a Regulatory Affairs Specialist to join their team. This is an established client within its niche of products, consisting mainly of class III devices. As one of Europe's leading suppliers they are able to offer a dynamic work place in a growing company where you will have plenty of challenges coming up.

The role will focus mainly on compiling and submitting technical documentation, Post-market Surveillance, PSUR's and overall review of other documentation. The role is mainly focused towards the EU, so one task will be to work with CE-marking for example but it would be meriting if you also have experience of working towards the FDA. This is a fairly independent role meaning you should have at least a few years experience with similar tasks.

This is a permanent position.

Requirements:

- At a minimum 2-3 years of Regulatory Affairs Experience in the medical device field

- Having worked with Class III products would be highly meriting

- Must communicate fluent in English and Danish would be preferred also.

- Experience of compiling and submitting technical documentation, such as CE-mark is a requirement

For more information, please reach out to Anders Sandberg at NonStop Consulting by clicking apply below or by sending your CV to a.sandberg@nonstopconsulting.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, the Czech Republic, Luxembourg, Bucharest and Boston and we hold labour leasing licences across Europe. Please visit our website for full list of the niche markets we cover.