Revvity | About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.
Find your future at Revvity.
REGULATORY AFFAIRS MANAGER
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 stakeholdersin order toexpedite 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)
What we offer:
Hybrid
Inspiring leadership and exceptional employees
Dynamic and innovative culture
Focus on career development
Collaborative and diverse environment
Interviews will be started immediately
Apply latest Nov 8th, 2024
Yifeng (Sr. Manager, Regulatory Affairs) free at 23.10 14-15, 30.10 13-14 +358503791124
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