Specialist within Biological Safety
Ph.D., KTH Stockholm
Available for: Part-time, full-time, tasks
Contact us for full CV
Profound proficiency within regulatory requirements including design controls (ISO13485), risk management (ISO14971), biological testings (ISO10993-*) and IEC 60601-1.
Alignment of test system — qualification, verification, validation — of products, supporting biological safety.
Process Validation within an ISO 13485 environment comprising IQ, OQ and PQ, according to GHTF/SG3/N99-10:2004.
Lifecycle Analysis according to applicable standards.
Coordination of global network within biological safety.
Instrumental in the development of Biological Safety system at GN Hearing.
Accountable for the biological safety at GN Hearing.
Founder of start-up company CytaCoat AB (www.cytacoat.com)
Implementation of test strategy.
Software and Standards
- Microsoft Windows
- Microsoft Office 365
- Multivariate analysis (MANOVA)
- JMP Software
Extensive knowledge in:
- ISO10993-* (Class IIa)
- US FDA regulation 21 CFR Part 820
- IEC 60601-* regulation impacting medical device
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).
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us