Regulatory Affairs Manager-Career jump-Nordics

Location
Sweden
Salary
€60000 - €61000 per annum + bonus and car
Posted
Oct 09, 2016
Closes
Nov 08, 2016
Ref
RK - 138943 - 1
Contact
Rositsa Kondaklieva
Jobseeker Type
Professional
Organization Type
Corporate
Contract Type
Employee
Hours
Full Time

Regulatory Affairs Manager - Career jump - Nordics

My client, a world leader within in Medical Device Industry and is looking for an Experienced Regulatory Affairs specialist to join their team. The job and the company will give you the opportunity to get international exposure and become responsible for a whole portfolio of innovative products. You will have the opportunity to provide regulatory support all post market activities across the whole region of Nordics.

Why move? For the international exposure - you will cover 5 countries and will have the autonomous and decision making power to make things happen!

On this role you will be in charge of following if the company meets all PMS requirements as provided in the Medical device directives. You will be working directly with the EU RA/QA teams and will be the first point of contact for the Nordics Competent authorities. In addition, you will be involved with training to all new starters as well as liaising between the regulatory and other technical teams (cross-functional focus).

The role reports to the RAQA Manager for EU, who is sitting in the UK

Requirements:

  • 3+ years in the area of RA for Medical Devices
  • Expert knowledge on all MD Directive laws
  • Knowledge of ISO9001 and ISO13485
  • You have worked previously with Notified bodies
  • Local/ International experience in the area

If you would like to hear more about this position then please contact Rositsa Kondaklieva on +44 207 940 2105 or alternatively send me an up to date copy of your CV by email to r.kondaklieva@nonstop-recruitment.com.

Requirements:

  • 3+ years in the area of RA for Medical Devices
  • Expert knowledge on all MD Directive laws
  • Knowledge of ISO9001 and ISO13485
  • You have worked previously with Notified bodies
  • Local/ International experience in the area

If you would like to hear more about this position then please contact Rositsa Kondaklieva on +44 207 940 2105 or alternatively send me an up to date copy of your CV by email to r.kondaklieva@nonstop-recruitment.com.