Hi, I'm RAMIN PARCHETALAB - Quality & Regulatory Leader | Medical Device | Digital Health | Surgical Robotics | FDA/EU MDR Expert | Quality management systems | Post Market surveillance | Biotechnology | AI/ML Quality Expert
I'm passionate about blending deep quality expertise with cutting-edge medical device innovation, especially in digital health and surgical robotics. I thrive on navigating complex regulatory landscapes and building robust systems where technology meets patient care.
At a glance
Curated signals on strengths, focus areas, and how they can help.
Interned at Cirtec Medical Systems, a leading component manufacturer for the medical device industry.
Currently serving as a Director of Quality Assurance, driving quality systems for innovative medical technologies.
Can help others by providing expert guidance on medical device quality systems and regulatory strategy.
🚀 Career trajectory
Foundation in Biotechnology & IVD
Gained comprehensive experience in design, development, and manufacturing quality within the biotech and IVD sectors, including supplier quality engineering.
✦ Biotechnology
✦ IVD
✦ Supplier Quality
Pioneering Quality in Digital Health & Robotics
Transitioned to leading quality assurance for innovative medical devices, including software quality engineering at Google and Director roles in surgical robotics.
✦ Digital Health
✦ Surgical Robotics
✦ Software Quality
Elevating Quality in Medical Device Sector
Currently focusing on senior leadership roles in medical device quality and regulatory, with a strong emphasis on design control and global compliance.
✦ Medical Devices
✦ FDA
✦ EU MDR
✦ Senior Management
💪🏻 Superpowers
Master of Medical Device Compliance
Navigating the intricate global regulatory maze for cutting-edge health technologies.
✦ Expert in FDA, EU MDR, ISO 13485, and IVDR.
✦ Proven success in design control and GxP environments.
✦ Skilled in CER construction and risk management (ISO 14971).
Digital Health & AI Quality Architect
Ensuring quality and safety in advanced software and AI/ML-driven medical solutions.
✦ Specializing in IEC 62304 for software life cycle development.
✦ Expertise in AI/ML quality considerations for medical devices.
✦ Proficient in computer system validation and U.S. Title 21 CFR Part 11.
Strategic Quality Systems Integrator
Building and optimizing quality frameworks for product lifecycle success.
✦ Extensive experience in establishing QMS and driving continuous improvement.
✦ Skilled in supplier quality, audits, and non-conformance management.
✦ Proficient in statistical analysis tools like Minitab and DOE.
I'm excited about
✦ Seeking to connect with innovators in AI/ML for medical devices.
✦ Looking to explore collaborations in digital health startups.
✦ Eager to share insights on navigating complex global regulatory environments.
I can help with
✦ Provide expert guidance on medical device quality systems and regulatory strategy.
✦ Offer insights into building robust software quality engineering processes.
✦ Share best practices for supplier quality management and audits.
I would love your help on
✦ Connections with leaders in emerging digital health technologies.
✦ Opportunities to discuss advancements in AI/ML for healthcare.
✦ Insights into novel approaches for post-market surveillance.