After one year of employment Randi Hauerberg becomes partner in Medicologic A/S.
Randi Hauerberg came on board as Principal Advisor/Team Lead on March 1, 2016 and has since then contributed with her professional expertise and personal skills to the positive development of the Regulatory Affairs & Quality Management business in Medicologic.
Through our partnership we are looking forward to the fantastic opportunity of being able to grow Medicologic as one of the leading international management consulting companies helping customers particularly within the Regulatory Affairs & Quality Management area.
Medicologic’s customers are customers within the Medical Device segment who are facing tremendously challenges within the regulatory and quality management area by constantly, complex and changing legislative requirements in order to obtain or maintain approval of their medical device products.
“Based upon the constantly changes within the legislative area, and particularly within the forthcoming new regulation within Medical Device and IVD I see – during the next 3 to 5 years – a fantastic opportunity helping our customers through the complex regulatory landscape”, says Randi Hauerberg.
Our competences within Regulatory Affairs & Quality Management is based upon highly skilled, professional consultants with more than 25 years’ experience helping customers through the least burdensome pathway with emphasize on speed-to-market and turnkey.
Randi Hauerberg has more than 25 years’ experience within Regulatory Affairs, having submitted and obtained worldwide approval of numerous products within medical devices and in vitro diagnostics such as CE labeling according to MDD 93/42/EC, IVDD 98/79/EC, FDA 510(k) clearances and PMA approvals, Health Canada, CFDA, PMDA, KFDA, Brazil, Mexico, and Russia etc.
For the last 5 and a half year she has worked as Regulatory Affairs Lead Manager for BK Medical Ultrasound (Analogic Ultrasound).
Her many years of experience within Regulatory Affairs from manufacturers of medical devices and in vitro diagnostics combined with direct responsibility towards the authorities, contributes to her extensive knowledge about regulatory requirements worldwide in combination with obtaining regulatory approval with a focus upon speed to market and turnkey.
Randi has also been appointed as Official Correspondent towards FDA and Health Canada and overall responsible for CE labeling.
She has previously held positions within Regulatory Affairs with Ferrosan A/S, Dako, Radiometer, PNN Medical, and BK Medical. Randi is also Chairman of the RA Expert Group outside EU, a member of the RA Expert Group within EU at Medicoindustrien. She has previously been a member of S-264 which is the Standardization Committee within IVD.
During her many years of experience she has contributed successfully to development projects, clinical, technical, marketing, sales and support, and approval of medical devices and in vitro diagnostics.
Direct (+45) 20 64 41 46
Principal Advisor/Team Lead – Regulatory Affairs & Quality Management
Direct (+45) 22 47 01 55