ID1070
Senior Consultant, Regulatory Compliance
DNV, PhD – Copenhagen University
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Regulatory compliance for medical devices and combination products
- Quality systems (ISO 13485, MDR, IVDR, MDSAP)
- Clinical and regulatory strategies for medical devices and pharmaceuticals
- Post-market surveillance and vigilance
- Certification processes and notified body interactions
- Risk management and pharmacovigilance
- Technical documentation, CER, PER, PMCF plans and reports
- Interaction with competent authorities and industry stakeholders
- Expert assessments and training in regulatory frameworks
Key results
- Managed certification processes and compliance for Presafe Denmark (NB 0543)
- Oversaw international regulatory compliance strategies for medical devices and combination products
- Led multiple notified body audits and regulatory submissions
- Developed and implemented post-market surveillance and vigilance strategies
- Conducted clinical and regulatory due diligence for medical device approvals
- Provided strategic regulatory support to companies navigating MDR/IVDR transitions
Software/Standards
EU Regulations & Directives:
- Medical Device Regulation (MDR 2017/745)
- In Vitro Diagnostic Regulation (IVDR 2017/746)
- MDD 93/42/EEC (Medical Device Directive)
- IVDD 98/79/EC (In Vitro Diagnostic Directive)
- ISO 13485 (Quality Management System for Medical Devices)
- EN ISO 14971 (Risk Management for Medical
Devices)
US Regulations & Standards:
- FDA 21 CFR Part 820 (Quality System Regulation)
- FDA 21 CFR Part 4 (Combination Products)
- FDA 21 CFR Part 11 (Electronic Records &
Signatures) - FDA 510(k) & PMA Submissions
- FDA Post-Market Surveillance & Vigilance
Personal Characteristics
Global Standards & Certification Systems:
- MDSAP (Medical Device Single Audit Program)
- ISO 14155 (Clinical Investigations of Medical
Devices) - IEC 62304 (Software Lifecycle for Medical Devices)
- IEC 60601 (Electrical Safety for Medical Devices)
- ISO 10993 (Biological Evaluation of Medical Devices)
- ICH Guidelines (International Council for
Harmonisation) - GCP/GMP (Good Clinical/ Manufacturing Practice)
He is an analytical, detail-oriented, and structured professional with a strong regulatory and clinical background.
His expertise spans across medical devices, pharmaceuticals, and combination products, ensuring compliance with global regulatory frameworks.
He thrives in cross-functional collaborations and enjoys tackling complex regulatory challenges.
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