Merja Vainio
Compliance Manager at Biohit Oyj- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
Helsinki, Uusimaa, Finlande, FI
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Experience
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Biohit Oyj
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Finland
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Biotechnology Research
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1 - 100 Employee
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Compliance Manager
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janv. 2022 - - aujourd’hui
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Medfiles
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Finland
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Regulatory Affairs Expert
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sept. 2018 - janv. 2022
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Productization manager
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août 2010 - août 2018
Productization of medical devices - Productization of medical device from product idea to market in a way it fulfills the regulatory requirements. Development of quality management based on EU standards. Ce-marking process. Productization of medical devices - Productization of medical device from product idea to market in a way it fulfills the regulatory requirements. Development of quality management based on EU standards. Ce-marking process.
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Mobidiag, A Hologic Company
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Finland
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality manager
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janv. 2003 - août 2010
Development and maintaining the quality management system based on ISO-standards 9001 and 13485. Development of CE-marking process
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Lab manager
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juil. 2001 - déc. 2002
R&D of in-vitro diagnostic tests
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Community
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