Regulatory Affairs Specialist
PerkinElmer, Wallac Oy

Alkuperäinen julkaisupäivä 12.4.2018

PerkinElmer is currently looking for Regulatory Affairs Specialist

Turku, Finland / Diagnostics

The Turku Site, with 550 employees, represents one of PerkinElmer’s major manufacturing and product development sites for newborn-, maternal fetal health-, and prenatal screening. As the global market leader in newborn screening, our solutions have tested over 560 million babies worldwide for life-threatening diseases.

Role description:

  • Prepare/submit global in vitro diagnostic device registration documents for international agencies worldwide
  • Oversee the implementation of international regulatory requirements of specified new and existing products as well as follow the specified geographic region medical device /IVD regulations.
  • Interact with global regulatory affairs managers/distributors in order to expedite approval of upcoming and pending registrations to ensure timely approval for market release
  • Ensure that regulatory considerations are evaluated and addressed during change control process, and implement regulatory action plans based on the changes
  • Deputy for maternity leave (temporary role for about 1 year)

Role requirements:

  • B.Sc or M.Sc or equivalent in biochemistry/biotechnology
  •  Understanding of CE IVD (98/79/EY) Directive and international IVD regulations
  • Excellent organization and communication skills
  • Ability to multi-task and work independently in global team environment
  • Fluent English (spoken and written)

What we offer:

  • Opportunity to work in a global team
  • Dynamic and innovative culture
  • Focus on career development
  • Collaborative and diverse environment

PerkinElmer Turku Site is a drug free site and a medical examination for new employees includes a drug test.

For more information on the open positions please contact Kirsi-Marja Meri, Leader of Global Regulatory Affairs, kirsi-marja.meri@perkinelmer.com or by phone +358 40 5808378 on April 23rd between 12– 13 and on April 25th  between 12 – 13.

At PerkinElmer we offer challenging opportunities to work in a global environment and the possibility to develop your professional skills. If you are interested in the position and feel that you have the necessary skills and experience, please apply with your CV and cover letter via the link below by May 7th, 2018.

PerkinElmer Turku Site is a drug free site and a medical examination for new employees includes a drug test.

 

Lisätiedot

  • Ilmoitusnumero: 1125688
  • Työsuhde: Määräaikainen työsuhde
  • Työn tyyppi: Kokopäiväinen
  • Hakuosoite: www-osoite
  • Sijainti: Turku