Maria Petroni

I am a Chartered Engineer (MSc Biomedical/Medical Engineering) with a background in Medical Technology, including medical devices, combination products, and in vitro diagnostics (IVDs).

With over 5 years of experience in Quality Assurance (QA), Regulatory Affairs (RA), and Quality Control (QC) for Class I to III medical devices, I assist medical technology (MedTech) companies in achieving global market access and maintaining regulatory and quality compliance throughout the entire product lifecycle.

I have built lean, audit‑ready Quality Management Systems (QMS) aligned with ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820, and other relevant international standards, accelerating approvals, and ensuring sustainable compliance across EU, US, Switzerland, and APAC markets.

🔹 𝐀𝐝𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐁𝐚𝐜𝐤𝐠𝐫𝐨𝐮𝐧𝐝:

I also bring expertise in Nuclear and Mechanical Engineering, with a focus on radiation‑based medical and industrial equipment, ensuring compliance, safety, and performance.

🔹 𝐋𝐚𝐧𝐠𝐮𝐚𝐠𝐞𝐬 & 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧:

• Italian (native), English (fluent), German (TELC B1 certified; currently B2), French (A2)
• I am based in the Zurich Area, Switzerland | Swiss C‑Permit.

🔹 𝐂𝐚𝐫𝐞𝐞𝐫 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡:

I collaborate across functions to turn regulatory and quality challenges into practical, sustainable solutions, fostering a strong quality culture and enabling technologies that improve patient outcomes.

🔹 𝐎𝐩𝐞𝐧 𝐓𝐨:

𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐢𝐧 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐀𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞, 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐟𝐟𝐚𝐢𝐫𝐬, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐂𝐨𝐧𝐭𝐫𝐨𝐥, 𝐨𝐫 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐰𝐢𝐭𝐡𝐢𝐧 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐌𝐞𝐝𝐓𝐞𝐜𝐡, 𝐨𝐫 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠.

📩 𝐅𝐞𝐞𝐥 𝐟𝐫𝐞𝐞 𝐭𝐨 𝐜𝐨𝐧𝐭𝐚𝐜𝐭 𝐦𝐞 𝐯𝐢𝐚 𝐞𝐦𝐚𝐢𝐥: 𝐦𝐚𝐫𝐢𝐚𝐩𝐞𝐭𝐫𝐨𝐧𝐢𝟐𝟎𝟐𝟒@𝐠𝐦𝐚𝐢𝐥.𝐜𝐨𝐦

🔹 𝐊𝐞𝐲 𝐒𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐬:

• Regulatory Affairs: EU MDR 2017/745, Swissmedic, FDA 510(k), PMA, De Novo, CE Marking
• Quality Systems: ISO 13485 QMS, CAPA, non‑conformities, change control, audits/FDA inspections
• Risk Management & Design Control: ISO 14971, Design History File, Device Master Record, Technical Files
• Post‑Market Surveillance: Global Process Owner / Single Point of Contact /SME
• Manufacturing & Supplier Quality: Supplier Quality Management, GMP, and Labeling Compliance
• Verification & Validation (Subject Matter Expert ): HW/SW V&V, CSV, IQ/OQ/PQ
• Regulatory Liaison: Swissmedic, FDA, Notified Bodies
• Devices Experience: Lung Ventilators, Orthopedic and Ceramic Dental Implants, X‑ray Computed Tomography.

Please see my attached CV. Thank you!

 

 Chartered Professional Engineer Certificate in Nuclear Engineering with a Major in Biomedical Engineering & Design, Faculty of Engineering, University «La Sapienza» and Council of Engineering, Rome, IT. Master of Science in Nuclear Engineering with a major in Biomedical Engineering & Design (Medical Technology: Medical Devices, Combination Products, In Vitro Diagnostics), Faculty of Engineering, University «La Sapienza», Rome, IT.