Jay Zbaczyniak

Q: What is Jay Zbaczyniak email address?

Email Jay Zbaczyniak at jay.zbaczyniak@caireinc.com. This email is the most updated Jay Zbaczyniak's email found in 2026.

Q: How to contact Jay Zbaczyniak?

To contact Jay Zbaczyniak send an email to jay.zbaczyniak@caireinc.com. (updated on September 05, 2024)

Regulatory Affairs Specialist at CAIRE Inc. | Buffalo-Niagara Falls Area

About Jay Zbaczyniak

Jay Zbaczyniak serves as a Regulatory Affairs Specialist at CAIRE Inc., where he plays a pivotal role in ensuring compliance with stringent regulatory standards and quality management systems. With a robust background in regulatory compliance, Jay is adept at navigating complex frameworks such as ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR 820, which are critical for the development and marketing of medical devices. His expertise extends to managing vigilance and adverse event reporting, where he oversees the coordination of these essential processes to ensure patient safety and regulatory adherence.

In his current role, Jay is the CAPA Program Coordinator, responsible for initiating and assigning Corrective and Preventive Actions across the company's facilities in both the US and EU. He leads CAPA Board approval meetings, meticulously monitors the status of CAPAs, and guides them to closure, ensuring that all actions taken are effective and compliant with industry standards. His recent migration of the CAPA program has streamlined processes, enhancing the efficiency of quality investigations and complaint handling.

Jay's proficiency in post-market surveillance and change control further solidifies his position as a key player in CAIRE Inc.'s commitment to quality management and regulatory excellence. His skills in quality management consulting and communication training allow him to effectively collaborate with cross-functional teams, fostering a culture of compliance and continuous improvement. With a keen eye for detail and a strategic approach to regulatory affairs, Jay Zbaczyniak is instrumental in driving CAIRE Inc. towards achieving its quality and regulatory goals, ultimately contributing to the safety and efficacy of its medical products in the market.

Jay Zbaczyniak Work