Regulatory Affairs Manager

at  Revvity

TURKU, FINLAND

Are you a regulatory professional who is seeking for new challenges?
Revvity Turku site is now looking for a new team member to join our Regulatory Affairs team. Turku site represents one of Revvity’s major manufacturing and product development sites for newborn and maternal fetal health screening. As the global market leader in newborn screening, our products are placed on the market globally.
As a Regulatory Affairs manager in Revvity Turku site, you will play a key role in our projects and work with global stakeholders.
Revvity’s Turku site has over 500 employees and is a key location for manufacturing and product development in newborn, maternal-fetal health, and prenatal screening. As a global leader in newborn screening, our solutions have tested over 700 million babies worldwide for life-threatening diseases.

ROLE DESCRIPTION:

• Develops and implements regulatory strategies for new and modified products
• Represent RA Department in project meetings and form regulatory assessments
• Providing RA input and guidance throughout the product development cycle, and coordinating team inputs for submissions, as well as provides input on and reviews plans and reports for design documents
• 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 stakeholders in order to expedite approval of upcoming and pending registrations to ensure timely approval for market release

ROLE REQUIREMENTS:

• B.Sc or M.Sc or equivalent in biochemistry/biotechnology
• Minimum of 5 years of work experience in IVD industry Regulatory Affairs or equivalent
• Expertise in IVDR (Regulation 2017/746) and international IVD regulations
• Familiar with IVD software and instrument is advantage
• Excellent organization and communication skills
• Proactive and can-do attitude
• Ability to multi-task and work independently in global team environment
• Finnish language and Fluent English (spoken and written)