ID1059
Senior RA/QA Software Specialist
B.Sc. IT & Electronics, DTU
M.Sc. Telecommunications, DTU
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Medical devices regulatory compliance (MDR)
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In vitro devices regulatory compliance (IVDR)
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Software:
Software for medical devices
Software as a medical device (SAMD) -
Project management (Prince2 / SCRUM Master)
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Product management (SCRUM Product Owner)
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Design control
Requirements Management
Usability engineering
Verification and Validation
Post Market Surveillance (PMS) -
Cyber security
Cyber security for companies
Cyber security for products -
Medical device certification
Technical file for CE marking
FDA 510(k) submission -
Risk Management
Product risk & Software risk
CAPA -
Internal and External Auditor
Key results
20+ career as project manager and consultant within software development for medical devices and as QA responsible.
A solid track record within project planning, coordination and deliverance.
Extensive knowledge of the regulatory landscape and market access requirements for medical devices in EU and US.
Built and certified several ISO 13485 quality management systems with focus on quality and maintainability.
Certified several products with the CE mark and FDA approval.
Focus on software development for medical devices and cybersecurity for companies and products.
Strong experience as technical writer for regulatory and quality standards with startup companies and within upgrading from MDD to MDR for existing medical products.
Project manager and director for interdisciplinary groups within software, mechanics and chemistry.
Software/Standards
- ISO 13485 – Medical devices – Quality Management Systems
- ISO 14971, ISO 24971 – Medical devices – Risk management
- EU Directives: Medical Device Directive MDD 93/42/EC, in vitro diagnostic directive IVDD 98/79/EC, AIMDD 90/385
- EU regulations: Medical device regulation 2017/745, In vitro diagnostic medical devices 2017/746
- FDA regulations: CFR 21 Part 820, Part 11
- IEC 62304, IEC 82304 – Medical device software and SAMD
- IEC 62366 – Usability engineering
- ISO/TR 20416 – Post Market Surveillance
- ISO 27001 – Information security, cybersecurity
- IEC 81001 – Health software and health IT systems safety
- ISO 15223-1 Labelling of medical devices
- Prince2, Professional Scrum Master & Product owner, SAFe
- Windows, Linux, Embedded Linux, Git, Jira, Confluence
- C++, Python, C#, Web API
- PyTest, PyCharm, Unit Test and Integration test
Personal Characteristics
Strong technical competences and communication abilities. Deep business understanding allows the consultant to cooperate on all levels. Excels within working processes, project planning, the technical development, managing contracts, and the ability to challenge technical solutions.
Hands-on experience with every aspect of quality management and Regulatory Affairs from startup companies and management experience for large international corporations. Good in creating target and directions for project teams and departments. Motivated to create effective and innovative solutions.
Focus on collaboration and effective solutions, organised and efficient to maintain milestones.
Knowledgeable regarding GMP solutions within QA, software development and medical device validation.
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