Lene Havsteen
Director Regulatory Affairs at Biograil
Based in Haslev, Denmark
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Seniority
Director
Department
Legal
Location
Haslev
Industry
Pharmaceutical Manufacturing
Company size
31
Contact information
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l•••••••@biograil.com
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Background
About Lene Havsteen
Regulatory and Vigilance Specialist With experienced within Medical products, Medical Device and Combination Products. Dedicated and committed Specialist with +20 years regulatory expirence in legal requirements and strategy in the EU and the US for Medicinal Products, Medical Devices and Combination Products as well as a specific knowledge within QMS, Post Marked Surveillance, Vigilance, Labelling, Patient Information Leaflet, technical documentation and clinical evaluation. Experiences within Regulatory Affairs, product information including multilingual labelling and user testing. Solid legal knowledge used proactive in order optimize patient safety and be complaint with legislative requirements. Personal engagement with a high level of personal drive and dedication. Team player used to have a lot on my plate and still have an eye for details, timelines and keep the overview.
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