Finland Job Openings
Revvity
Regulatory Affairs Manager
Turku
November 17, 2024
Turku, Finland
Are you a regulatory professional who is seeking for new challenges?
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:
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Develops and implements regulatory strategies for new and modified products
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Represent RA Department in project meetings and form regulatory assessments
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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
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Prepare/submit global in vitro diagnostic device registration documents for international agencies worldwide
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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.
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Interact with global stakeholders in order to expedite approval of upcoming and pending registrations to ensure timely approval for market release
Role requirements:
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B.Sc or M.Sc or equivalent in biochemistry/biotechnology
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Minimum of 5 years of work experience in IVD industry Regulatory Affairs or equivalent
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Expertise in IVDR (Regulation 2017/746) and international IVD regulations
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Familiar with IVD software and instrument is advantage
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Excellent organization and communication skills
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Proactive and can-do attitude
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Ability to multi-task and work independently in global team environment
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Finnish language and Fluent English (spoken and written)
What we offer:
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Hybrid
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Inspiring leadership and exceptional employees
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Dynamic and innovative culture
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Focus on career development
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Collaborative and diverse environment
If you have any questions you can contact:
Yifeng Li, Sr. Manager, Regulatory Affairs (+358503791124)
Revvity’s Turku office is a substance-free workplace, and new employees will undergo a drug test as part of the pre-employment medical examination.
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