ID1048
Senior Consultant Medical Device Compliance
MSc. Human Biology, Copenhagen University
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Design Control.
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Risk Management.
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CAPA.
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Design verification.
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Design validation.
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Human Factors / Usability.
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Requirement Engineering.
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Product maintenance.
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SAMD/SIMD/MDSW.
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Customer complaint investigation.
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Inspection preparation and presentations.
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Device accessories.
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Process optimization and cLEAN.
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Batch review and release of products as delegated QP.
Key results
Working with medical devices since my graduation has given me a holistic insight into the industry. I started my career in a medical device production as a delegated QP. I have extensive experience in product maintenance and R&D thus giving me valuable insights into the entire value chain.
I have a diverse profile with my biotechnological education combined with experience from both production, R&D and regulatory assignments. My background and career combined allows me to work with a wide range of subject areas from biologics over electronics to medical devices
Software/Standards
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SO13485:2016.
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MDR (device regulation).
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IVDR (In Vitro Diagnostics Regulation).
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FDA regulation [CFR part 820].
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ISO14971 (risk management).
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IEC 62366 (Device Usability).
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IEC 62304 (Device Software).
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IEC 82304 (Health Software).
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Microsoft Windows.
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Microsoft Office 365.
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Microsoft project.
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Microsoft Visio.
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Agile.
Personal Characteristics
I carry great concern for my co-workers and try my best to create a fun and positive environment. I thrive in a dynamic setting with short deadlines and difficult situations.
I enjoy being challenged by skilled colleagues as well as complex assignments in a busy environment. I am continuously trying to improve both at a personal and professional level.
As I have been working as quality representative most of my career, I am used to giving direction and setting boundaries according to the company guidelines. I am used to work in complex stakeholder situations in international companies with great diversity.
I am tech savy and a quick learner and can thus easily adapt to working with diverse and complex devices and software.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com