(Poistunut julkaisusta)

Regulatory Affairs Manager
PerkinElmer, Wallac Oy

Alkuperäinen julkaisupäivä 2.5.2018

PerkinElmer is currently looking for
Regulatory Affairs Manager

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
  • Participation on project teams to provide strategic and tactical guidance to meet regulatory requirements
  • Ensure that regulatory considerations are evaluated and addressed during change control process, and implement regulatory action plans based on the changes
  • Review and approve promotional materials and product labelling

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
  • Finnish language and 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

For more information please contact Leader of Global Regulatory Affairs Kirsi-Marja Meri on May 21st between 12 –13, or May 24th between 12 –13 +358 40 5808 378 or by e-mail Kirsi-Marja.Meri@perkinelmer.com.

If you are interested in the position and feel that you have the necessary skills and experience, please send your application and CV by 27th May, 2018 via the link below.

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