Regulatory Affairs Specialist/Manager
PerkinElmer, Wallac Oy
PerkinElmer is currently looking for a
REGULATORY AFFAIRS SPECIALIST/MANAGER
The Turku Site, with 650 employees, represents one of PerkinElmer’s major manufacturing and product development sites for newborn and maternal fetal health screening. As the global market leader in newborn screening, our solutions have tested over 560 million babies worldwide for life-threatening diseases.
- 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
- Temporary role for about 1 year
- B.Sc or M.Sc or equivalent in biochemistry/biotechnology
- Basic knowledge required on CE IVD (98/79/EY) Directive, IVDR (Regulation 2017/746) 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:
- Inspiring leadership and exceptional employees
- Dynamic and innovative culture
- Focus on career development
- Collaborative and diverse environment
Please apply as soon as possible, at the latest on February 28th. For further information, please contact Leader of Global Regulatory Affairs, Kirsi-Marja Meri, +358 2 2678 231, preferably on Monday, February 22nd between 12 - 13, or on Thursday, February 25th between 14 - 16. Join us today!