07/03/2026 updated
100 % available
Regulatory Affairs and Quality Consultant | ISO 13485 and ISO 9001 QMS, EU MDR/IVDR and FDA QSR
Malmo, Sweden
Germany +10
Master Quality Management, Master Finance and Marketing, Master Food Technologyinfo: Germany, Austria, Switzerland, United Kingdom, France, Belgium, Denmark, Ireland, Netherlands, Norway, Sweden
About me
Senior RA/QA leader with 20+ years in life sciences: devices, IVD, SaMD and pharma. Expert in EU MDR/IVDR transition and remediation, regulatory strategy, technical documentation, ISO 13485/9001 QMS, CAPA/change management, risk management, CE/FDA/EMA submissions, audit and inspection readiness.
AuditingComplianceISO 13485ISO 14971ISO 22000ISO 13485 StandardQC ReportingQuality ManagementSAP QMTotal Quality ManagementQuality StrategyISO 45001Regulatory AffairsRisk ManagementISO-14001
CORE SKILLS
RAQA Leadership, Regulatory Strategy and Quality Strategy
PRRC Requirements under EU MDR Article 15
EU MDR 2017/745 and IVDR 2017/746 Transition and Remediation
FDA QSR/QMSR Compliance
ISO 13485 and ISO 9001 QMS Management, Development, Remediation and Continuous Improvement, QMS Management Representative
Technical Documentation and Technical Writing: GSPR, CER/PER, PMS, PMCF/PMPF, PSUR, IFU and Labelling
CE Marking, UKCA Marking, Global Regulatory Submissions and Market Access
Notified Body, FDA and Regulatory Authority Interactions
Risk Management (ISO 14971)
CAPA Management, Change Management, Deviation Management and Product Compliance
Supplier Quality Oversight and Operational Compliance
Audit and Inspection Readiness: Notified Body ISO 13485/ISO 9001 Audits, FDA QSR/QMSR, and GMP/GDP Inspections
Vigilance Reporting and Field Safety Corrective Actions
Design Control, Product Development Support and Product Lifecycle Management
Cross-Functional Team Leadership and Stakeholder Management
Regulatory and Quality Project Management
SAP Quality Management Module Implementation and Demand-to-Sales Process Support
Medical Device, SaMD, IVD, Pharmaceutical and Food Compliance
CERTIFICATIONS & PROFESSIONAL TRAINING
Regulatory, Digital Health & AI Compliance
Medicine and Medical Devices Training
EU AI Act for Medical Devices & High-Risk AI Systems Training
FDA AI/ML-Enabled Medical Device Software & SaMD Training
Product Development Lifecycle Training
Cybersecurity Training
Pharmacovigilance Training
GxP, Validation & Quality Systems
GMP Deviation Investigation & CAPA Training
GDP Training
Change Management Training
Computer System Validation (CSV) Training
Validation Master Plan Training
Risk Management, Audit & Inspection Readiness
Risk Management & FMEA Training
Supplier Audits Training: ISO 9001, ISO 14001, ISO 45001
Integrated Management Systems Internal Auditor Training: ISO 9001, ISO 22000
IRCA FSMS Lead Auditor Certification
Quality, Process Control & Operational Excellence
Total Quality Management Training
HACCP Systems & CCP Analysis Training
Statistical Process Control (SPC) and Measurement System Analysis (MSA) Training
Systems, Leadership & Business Management
SAP Key User Training: Quality, Demand-to-Supply
From Management to Leadership Training
Experience
Professional experience10+ years
Freelancer since2019
Languages
GermanGoodEnglishNative speakerPolishNative speakerSwedishBasic knowledge
Project history
- Drove MDD to MDR transition and EU MDR 2017/745 remediation as a core project team member for Class IIa/IIb devices, supporting CE marking, Notified Body interactions, global regulatory submissions, certification readiness, and regulatory compliance
- Served as Quality Approver for Technical Documentation, including GSPR, CER, PMS, PMCF, PSUR, IFU, labelling, SOPs, and change controls, ensuring compliance with EU MDR, ISO 13485 QMS, FDA QSR, and global regulatory requirements
- Provided regulatory and quality guidance on EU MDR certification processes, supporting design control, risk management (ISO 14971), PMS, product development, and lifecycle management
- Strengthened ISO 13485 QMS processes to support EU MDR alignment and continuous improvement
- Partnered with Regulatory, Quality, Clinical, R&D, Manufacturing, Commercial, and Labelling teams to support regulatory compliance and effective execution across product lifecycle activities
- Led Technical Documentation ownership for a Class D COVID-19 IVD, ensuring IVDR and UK MDR compliance and Technical File readiness
- Owned regulatory strategy to drive IVDR compliance, market access, and product registrations
- Contributed to CER development, supporting IVDR compliance gap closure and clinical evidence alignment
- Supported ISO 13485 QMS alignment with EU MDR requirements and QMS remediation activities, ensuring process compliance, audit readiness
- Collaborated with cross-functional teams across Regulatory, Quality, Clinical, R&D, Manufacturing, Scientific, and Commercial functions to align development, regulatory, and quality activities across the product lifecycle
- Led EU MDR 2017/745 transition and remediation, regulatory submissions, and product lifecycle management
- Owned regulatory strategy and provided cross-functional Regulatory Affairs and Quality leadership for Class IIa Software as a Medical Device (SaMD), ensuring compliance with EU MDR 2017/745
- Owned Technical Documentation, including GSPR, CER, PMS, PMCF, PSUR, vigilance, risk management (ISO 14971), and Technical File readiness, leading CE marking activities and Notified Body interactions
- Managed ISO 13485 QMS alignment with EU MDR requirements, including CAPA, change control, and continuous improvement initiatives
- Led Notified Body audit preparation, resulting in successful ISO 13485 recertification, and ensured FDA inspection readiness