16.10.2026 aktualisiert
100 % verfügbar
Interim Quality & Regulatory Director / Life Sciences Executive
Schlieren (Zurich), Schweiz
Weltweit
BSc in Computer EngineeringÜber mich
20+ years of experience across MedTech, BioTech, Pharma and manufacturing industry. My main skills are: QMS, Technical File for Class I until class III MDs, qualification/verification/validation (incl. CSV), internal, external and supplier audits and much more. See what I can offer below!
Skills
21 CfrAuditmanagementPrüfungsplanungISO 9000Korrektur- und VorbeugemaßnahmeChange ManagementBeratungFmeaIncident-ManagementIso 13485ISO13485ProjektmanagementQualitätsmanagementRisikoanalyseVerifizierung und Validierung
WHAT I CAN OFFER:
QMS Strategy & Regulatory Compliance
- QMS Frameworks: Designing, implementing, and scaling Quality Management Systems from scratch (ISO 13485, ISO 9001, FDA 21 CFR Part 820, GxP).
- MDR Roadmap: Defining the EU MDR compliance roadmap and executing systematic gap analyses to align processes with evolving international regulations.
- Technical Documentation: Managing Technical Files (DHF/DMR/DHR) for medical devices spanning from Class I to Class III, including SaMD according to IEC 62304.
- Regulatory Operations: Authoring and reviewing critical regulatory documentation to secure global product registrations.
- PRRC Support: Fulfilling and supporting legal and operational duties as the Person Responsible for Regulatory Compliance (PRRC).
- FDA 510(k): Prepararing all documentation to ensure the successful outcome of 510(k) submissions to the FDA.
Process Governance & SOP Management
- SOP Optimization: Authoring, implementing, and optimizing QMS Standard Operating Procedures (SOPs) to elevate operational efficiency.
- Supplier Quality: Managing comprehensive supplier qualification frameworks and oversaw rigorous incoming inspection activities.
- Change Control: Facilitating end-to-end change control requests to guarantee continuous compliance across all engineering and operational shifts.
Validation & Engineering Governance
- Equipment Qualification: Executing global qualification, verification, and validation protocols for manufacturing equipment and processes.
- Computer System Validation: Directing CSV activities strictly adhering to FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Risk Management, Audits & PMS
- Risk Mitigation: Spearheaded cross-functional FMEA sessions and moderating complex risk analysis tracks.
- CAPA Ownership: Resolving product deviations and non-conformities by owning and driving robust CAPA systems.
- Audit Defense: Leading cross-functional teams through internal, supplier, and high-stakes Notified Body/FDA external regulatory audits.
- PMS & Clinical Support: Supporting clinical trials, Post-Market Surveillance (PMS) plans and reports (PSUR), and global vigilance activities.
- Talent Development: Designing and delivering targeted technical and compliance training sessions for site personnel.
WHERE:
- Zurich Region (On-site, Hybrid, Remote).
- Rest of Switzerland (Hybrid with sporadic presence on-site or Remote).
- Europe and Rest of the World (Remote only).
RATE:
- Happy to provide you with a personalized quote tailored to the specific needs of your project!
CONTACTS:
- Fill out the "Contact Form" at the end of this page, or
- Contact me in my LinkedIn profile: www.linkedin.com/in/ivan-maggio-a333418
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2026
Sprachen
DeutschgutEnglischverhandlungssicherItalienischMuttersprache
Projekthistorie
- Regulatory Approval: Successfully built from scratch and maintained a comprehensive QMS compliant with EU MDR (ISO 13485) and GxP (i.e. GMP, GCP, GLP, GDP, GVP) standards, securing Swissmedic clinical trial approval for a Class IIa combination therapy injection device.
- Technical File Leadership: Authored, updated, and managed the complete Technical Documentation lifecycle, including Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).
- Operational Excellence: Established and executed core quality processes covering CAPA systems, deviations, non-conformities, risk analyses, and change controls to ensure continuous compliance.
- Audit & Supplier Management: Spearheaded the supplier qualification program and conducted rigorous internal and external supplier audits against ISO 13485 and ISO 9001 standards.
- Validation & Maintenance: Directed all facility validation, equipment qualification (IQ/OQ/PQ), verification protocols, and routine maintenance schedules.
- Team Leadership & Training: Managed a quality team of 2 direct reports and designed a company-wide GxP training program, significantly increasing compliance awareness across SOPs and Work Instructions (WIs).
- Clinical Trial: Collaborated with cross-functional teams to monitor and maintain the highest quality and GCP compliance standards during Phase II clinical operations.
- Department Leadership: Commanded the entire quality department as Head of Quality, establishing QA/QM strategic direction for the company's multi-device platform.
- QMS: Maintained and optimized the full QMS, successfully achieving consecutive annual ISO 13485 and MDR certifications.
- Core QA Operations: Orchestrated quality processes, including CAPA systems, incoming inspections, deviations, non-conformities, risk analyses, and rigorous internal/external/supplier audits.
- Validation & Maintenance: Directed verification, validation, and qualification protocols alongside routine equipment maintenance schedules.
- Multi-Market Compliance: Steered regulatory strategies ensuring strict alignment with Swissmedic, MDD/MDR, and FDA requirements for Class I, IIa (SaMD), and III MDs.
- Technical File (TF): Authored and updated comprehensive TFs (DHF, DMR, DHR) directly securing successful annual DNV MEDCERT audits and CE marking, furthermore supporting successful FDA 510(k) submissions.
- Post-Market: Managed PMS, product vigilance, and compliant registration of finished MDs.
- Investigator-Initiated Trial (IIT): Oversaw all quality documentation for IIT to ensure strict compliance with standards.
- Supply Chain: Managed corporate logistics and procurement operations, bridging the gap between quality compliance and timely production manufacturing.
- Supplier: Overhauled the supplier qualification and management program to secure reliable, compliant components for high-risk (Class III) MDs.
- Validation Framework Launch: Architected and implemented the complete validation and verification infrastructure from scratch for a Class III active implantable pump system (alfapump).
- Regulatory Compliance & Audits: Authored and maintained the foundational Validation Policy SOP, Validation Master Plan (VMP), and Validation Master Report, directly securing successful annual BSI audits and CE marking.
- Global Standards Alignment: Ensured absolute compliance across all validation documentation with ISO 13485, FDA 21 CFR Part 820 (Quality System Regulation), and FDA 21 CFR Part 11 (Electronic Records).
- Cross-Functional Qualification: Managed and executed comprehensive validation, verification, and qualification protocols across manufacturing processes, test equipment, and specialized production tools.
- Computer System Validation (CSV): Directed the Software and Computer System Validation lifecycle to guarantee data integrity, software reliability, and system compliance.
- eQMS Lifecycle Integration: Collaborated actively across core Quality Management System (QMS) workflows, leveraging electronic QMS (eQMS) platforms to streamline documentation and compliance tasks.