Sunder Gottumukkala currently serves as a Regulatory Affairs Consultant at Olympus Corporation of the Americas, where he leverages his extensive expertise in regulatory compliance and clinical evaluation to navigate the complexities of the EU Medical Device Regulation (MDR). With a robust background in consulting for...
Sunder Gottumukkala currently serves as a Regulatory Affairs Consultant at Olympus Corporation of the Americas, where he leverages his extensive expertise in regulatory compliance and clinical evaluation to navigate the complexities of the EU Medical Device Regulation (MDR). With a robust background in consulting for major players in the medtech industry, including DePuy Synthes and Smith and Nephew, Sunder has honed his skills in clinical evidence strategy and regulatory submissions. His role at Olympus involves remediating technical documentation to align with stringent EU MDR requirements, ensuring that products not only meet regulatory standards but also uphold the highest levels of safety and efficacy.
Sunder's key projects include leading the Regulatory Affairs & Labeling Remediation Project at Clinic Innovations, LLC, where he successfully guided cross-functional teams in reviewing and approving supporting documentation. His meticulous approach has been instrumental in preparing and submitting MDD certificate extension applications, as well as technical documentation for MDR certification. Additionally, Sunder adeptly manages responses to notified body queries, demonstrating his proficiency in navigating the regulatory landscape.
His skill set encompasses a wide array of regulatory frameworks, including General Data Protection Regulation (GDPR) and Good Manufacturing Practices (GMP), alongside a solid foundation in clinical trials and ICH guidelines. Proficient in tools such as Microsoft Word and Excel, Sunder combines technical acumen with strategic insight, making him a valuable asset in the ever-evolving medtech sector. His commitment to excellence and regulatory integrity positions him as a trusted consultant, driving compliance and innovation at Olympus Corporation of the Americas.
