ID1037
Project Manager Medical Devices
Medical Device Test and Compliance
Available for: Full-time, part-time, tasks
Contact us for full CV
Competences
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..Management and project management
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CEO experience in start up
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Medical Marketing and product launches.
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Design Controls and DHF.
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Design and implementation of QMS.
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Testing Strategies and Implementation.
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Implementation of the V-model.
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Design verification – Test protocols/test reports.
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Medical Device Files.
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Risk Management.
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Post Market Surveillance (PMS) and Vigilance.
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Experienced auditor.
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Management Representative.
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Qualified Person.
Key results
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Antia Therapeutics AG (CEO/Project Manager):
– Market introduction and sales of Easyx Liquid Embolic.
– Clinical Studies (Class IIB and Class III).
– Setting up supply chain.
– Setting up distribution.
– CE-Mark Class IIB.
– ISO 13485:2012 à 2016 certification. -
Prior to that multiple medical device product launches.
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Implementation of QMS and ISO 134845:2016 certification at RD-Support.
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Implementation of QMS at Optoceutics and Measurelet.
Standards
Extensive knowledge in:
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MDR 2017/745, IVDR 2017/746
[Medical Device & In Vitro Diagnostic Directive] -
ISO13485:2016 [Medical Device QMS]
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EN ISO 14971:2019 [Risk Management]
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EN ISO 19011:2018 [Internal Audit]
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MEDDEV 2.12-1 rev 8 [Vigilance]
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MEDDEV 2.7/1 revision 4 [Clinical Evaluation]
Personal Characteristics
He believes in practical solutions that works for people.
He has hands on experience in all aspects of startups and large medical device companies including extended Regulatory and Quality experience.
He can do the job himself as well as teach and coach.
He is an excellent cook and spend his free time mountain biking close to the summerhouse where he is also working on projects.
He is married for a lifetime and has two daughters.
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