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Global Regulatory Affairs & Quality Expert | Medical Devices, IVDR, EU MDR, FDA 510(k), ISO 13485
Lindau, Deutschland
Weltweit
PhD, Cellular & Molecular Biology – University of Bonn, GermanyÜber mich
Global RA & quality professional with 9 years in medical devices, IVD across EU, FDA 510(k) & Canada, APAC, LATAM, MENA for Class I-III devices incl. regulatory strategy & authority interactions. Expertise in EU MDR/IVDR, ISO 13485 & PMS. Hold RAC, PRRC & ISO 13485 Internal Auditor certifications.
Skills
ISO13485Regulatorischen Anforderungen
EU MDR/IVDR Regulatory Strategy & Submissions
Expertise in EU MDR (2017/745) and EU IVDR (2017/746) for Class I-III and Class A-C devices, including authoring STED dossiers, country-specific formats, CERs, and labelling reviews. Extensive experience with MDD-to-MDR and IVDD-to-IVDR transition and change assessments.
Global Market Access & Regulatory Registrations
Management of global regulatory registrations and renewals for Class I-III medical devices, IVDs, and SaMD across EU, US (FDA 510(k)), APAC, LATAM, MENA, Canada, NMPA China, MFDS, and TFDA. Track record of 500+ registrations across 50+ devices.
Post-Market Surveillance & Vigilance
Authoring and reviewing PMS SOPs, PMS reports, PSUR reports, and vigilance reports including incident and FSCA reporting. Experience with PMS tracking via Salesforce and coordination with regulatory authorities and Notified Bodies for compliance submissions.
ISO 13485 Quality Management & Internal Auditing
Certified Internal Auditor for ISO 13485 (TUV SUD). Leading change-control and impact assessments, authoring SOPs aligned with ISO 13485, and supporting internal and external audits including preparation of audit-ready documentation.
PRRC Responsibilities (Article 15 MDR/IVDR)
Certified PRRC (Article 15) with hands-on experience in lifecycle compliance and regulatory oversight across all product classes, including authority interactions with Notified Bodies, BfArM, FDA, and Health Canada.
ISO 14971 Risk Management
Certified in ISO 14971 Risk Management (TUV SUD). Application of risk management principles across medical device and IVD product lifecycles.
SaMD & IEC 62304 Software Regulatory Compliance
SaMD lead experience applying IEC 62304 and EN 82304 to connected diagnostic platforms and algorithm-driven signal-processing software, covering classification, documentation, and submission strategy.
Cross-functional Stakeholder & Team Management
Leading compliance activities across cross-functional teams and external partners. Coordinating global RA consultant networks and mentoring junior RA specialists.
Regulatory Intelligence & Change Management
Monitoring regulatory landscape changes and conducting impact assessments to ensure ongoing compliance with evolving requirements across multiple markets.
Combination Products & GMP-regulated Submissions
Regulatory Affairs support for combination products (drug-device), including contribution to submission SOPs in GMP-regulated environments and exposure to FDA 510(k) and EU frameworks.
Expertise in EU MDR (2017/745) and EU IVDR (2017/746) for Class I-III and Class A-C devices, including authoring STED dossiers, country-specific formats, CERs, and labelling reviews. Extensive experience with MDD-to-MDR and IVDD-to-IVDR transition and change assessments.
Global Market Access & Regulatory Registrations
Management of global regulatory registrations and renewals for Class I-III medical devices, IVDs, and SaMD across EU, US (FDA 510(k)), APAC, LATAM, MENA, Canada, NMPA China, MFDS, and TFDA. Track record of 500+ registrations across 50+ devices.
Post-Market Surveillance & Vigilance
Authoring and reviewing PMS SOPs, PMS reports, PSUR reports, and vigilance reports including incident and FSCA reporting. Experience with PMS tracking via Salesforce and coordination with regulatory authorities and Notified Bodies for compliance submissions.
ISO 13485 Quality Management & Internal Auditing
Certified Internal Auditor for ISO 13485 (TUV SUD). Leading change-control and impact assessments, authoring SOPs aligned with ISO 13485, and supporting internal and external audits including preparation of audit-ready documentation.
PRRC Responsibilities (Article 15 MDR/IVDR)
Certified PRRC (Article 15) with hands-on experience in lifecycle compliance and regulatory oversight across all product classes, including authority interactions with Notified Bodies, BfArM, FDA, and Health Canada.
ISO 14971 Risk Management
Certified in ISO 14971 Risk Management (TUV SUD). Application of risk management principles across medical device and IVD product lifecycles.
SaMD & IEC 62304 Software Regulatory Compliance
SaMD lead experience applying IEC 62304 and EN 82304 to connected diagnostic platforms and algorithm-driven signal-processing software, covering classification, documentation, and submission strategy.
Cross-functional Stakeholder & Team Management
Leading compliance activities across cross-functional teams and external partners. Coordinating global RA consultant networks and mentoring junior RA specialists.
Regulatory Intelligence & Change Management
Monitoring regulatory landscape changes and conducting impact assessments to ensure ongoing compliance with evolving requirements across multiple markets.
Combination Products & GMP-regulated Submissions
Regulatory Affairs support for combination products (drug-device), including contribution to submission SOPs in GMP-regulated environments and exposure to FDA 510(k) and EU frameworks.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2022
Sprachen
DeutschgutEnglischMuttersprache
Projekthistorie
Global regulatory strategy and registrations/renewals for Class I-III medical devices, IVDs, and SaMD across EU, US, APAC, LATAM, and MENA (500+ registrations, 50+ devices). Independently authored submission dossiers, coordinated with local registration holders, authored PMS SOPs and reports, led change-control and impact assessments, fulfilled PRRC (Art. 15) responsibilities, coordinated global RA consultant network, and supported economic operator obligations including Authorized Representative coordination.
RA support for combination products (drug-device); contributed to submission SOPs in GMP-regulated environment; exposure to FDA 510(k) and EU frameworks.
Global registrations (FDA 510(k), NMPA China, MFDS, TFDA, Canada, LATAM, MENA) for Class I-III devices. Authored MDR-compliant STED files, managed MDD-to-MDR change assessments, used Windchill PDMLink for document control, authored SOPs, supported vigilance and PMS activities, and supported internal and external audits including audit-ready documentation preparation.
Zertifikate
Internal Auditor ISO13485
TüV SüD2025
PRRC
TüV SüD2023
RAC (EU - Medical devices and Pharma)
RAPS - Regulatory Affairs Professional Soceity2019
Manager Regulatory
TüV Süd2018