Nihal Varadkar

Regulatory Affairs Specialist with a Master’s in International Regulatory Affairs from Northeastern University and proven expertise in global submissions, including EU MDR, FDA 510(k), PMA, Health Canada, ANVISA, and Japan PMDA. Skilled in Class I & II SaMD, MDD-to-MDR transitions, QSR, ISO 13485, IVDR, CMDR, GMP, and 21 CFR compliance. Experienced in authoring technical files, leading regulatory strategy, and supporting audits with FDA, Notified Bodies, and MDSAP countries.

Recognized for adaptability, cross-functional collaboration, and delivering successful submissions under tight deadlines.

I am a results-driven Regulatory Affairs professional with a Master’s degree in Regulatory Affairs from Northeastern University, specializing in International Regulatory Affairs. With hands-on experience at companies like EchoNous, Endologix, and Dentsply Sirona, I have successfully managed global submissions across multiple regions, including EU MDR, FDA, Health Canada, Brazil (ANVISA), and Japan. My expertise spans Class I and II SaMD, 510(k), PMA, IDE, and MDD-to-MDR transitions.

I have authored and reviewed technical files, supported product development teams with regulatory strategy, and coordinated submissions for MDSAP countries while navigating complex, evolving regulatory landscapes. I am also well-versed in QSR, ISO 13485, IVDR, CMDR, GMP, and 21 CFR requirements.

In addition to my technical expertise, I bring proven audit experience with FDA, Notified Bodies, ANVISA, and MDEL inspections. I thrive in fast-paced, cross-functional environments, and my ability to adapt quickly has been demonstrated through multiple promotions and successful project completions under tight timelines.

Passionate about advancing healthcare innovation through compliant and efficient regulatory pathways, I am seeking to contribute my skills to an organization that values quality, collaboration, and global market growth.

Masters in Regulatory Affairs from Northeastern University