Ivan Maggio

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.
• 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): Preparing 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).
• Switzerland (Hybrid with sporadic presence on-site or Remote)
• Rest of the World (Remote only).