ID1042
Specialist within Biological Safety
Ph.D., KTH Stockholm
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Profound proficiency within regulatory requirements including design controls (ISO13485), risk management (ISO14971), biological testings (ISO10993-*) and IEC 60601-1.
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Alignment of test system — qualification, verification, validation — of products, supporting biological safety.
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Process Validation within an ISO 13485 environment comprising IQ, OQ and PQ, according to GHTF/SG3/N99-10:2004.
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Lifecycle Analysis according to applicable standards.
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Coordination of global network within biological safety.
Key results
2017-2022
Instrumental in the development of Biological Safety system at GN Hearing.
2007-2018
Accountable for the biological safety at GN Hearing.
1999-2007
Founder of start-up company CytaCoat AB (www.cytacoat.com)
1995-2000
Implementation of test strategy.
Software and Standards
- Microsoft Windows
- Microsoft Office 365
- Multivariate analysis (MANOVA)
- JMP Software
Extensive knowledge in:
- ISO13485
- ISO14971
- ISO10993-* (Class IIa)
- US FDA regulation 21 CFR Part 820
- IEC 60601-* regulation impacting medical device
Personal Characteristics
Is a devoted principal for operations within biological safety, while considering the soft needs for customers. Very keen to meet the necessities of customers, both in time but also personal inter-relations.
Has 15 years of experience in medical device whereas the biological safety transformed from ‘nice to have’ to ‘a must’.
Has also been instrumental in the start-up company CytaCoat AB (www.cytacoat.com) operating within medical device products.
Is am furthermore expert (‘udvalgsmedlem’) at Dansk Standard (S-258).
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