Regulatory Affairs Specialist
Regulatory affairs expert with experience in FDA submissions, medical device compliance, and global regulatory strategies. Skilled in QMS, ISO 13485, and quality systems. Proven track record of success in navigating complex regulatory landscapes and driving business growth. Contact for quote for comprehensive regulatory services.
Experience: 5+ years
Submissions: 1 510(k)
Sravanthi Polavarapu provides regulatory consulting services to clients in:
Sravanthi Polavarapu holds a Master of Science in Biotechnology from Johns Hopkins University, with a concentration in Legal and Regulatory Affairs, and a Bachelor of Science in Biotechnology and Biology from Rutgers and St. Bonaventure University. Her academic background in biotechnology and regulatory affairs strengthens her regulatory expertise, enabling her to navigate complex regulatory landscapes effectively. Her education at prestigious institutions demonstrates her ability to succeed in demanding academic environments, which translates to her professional skills and regulatory acumen. This educational background positions her as a valuable asset for medtech companies seeking expertise in regulatory affairs.
Sravanthi Polavarapu brings extensive experience as a Regulatory Affairs Specialist, having worked with leading companies such as ALPCO, Siemens Healthineers, and Acara Solutions. In her senior roles, she successfully managed multiple FDA pre-submissions, achieved Health Canada clearance for Class II diagnostic assays, and led regulatory submissions for medical instruments. Her career progression showcases her depth of experience in regulatory affairs, with a focus on medtech compliance and strategy. Her achievements demonstrate her ability to drive business growth and navigate complex regulatory requirements, making her a compelling choice for medtech companies seeking regulatory expertise. Her experience working with global regulatory teams and staying up-to-date on regulatory requirements highlights her ability to adapt to evolving regulations.
Regulatory affairs expert with experience in FDA submissions, medical device compliance, and global regulatory strategies. Skilled in QMS, ISO 13485, and quality systems. Proven track record of success in navigating complex regulatory landscapes and driving business growth. Contact for quote for com...
Sravanthi Polavarapu offers a potent combination of specialized expertise and big-medtech experience, making her an invaluable asset for diagnostic companies. With 5 years focused on the IVD space, her background at Siemens Healthineers provides deep insight into navigating complex quality systems and product development lifecycles. Her proven track record, including managing multiple FDA pre-submissions and successfully achieving Health Canada clearance for Class II assays, demonstrates a clear ability to execute on critical regulatory milestones. This practical success, underpinned by a specialized Master's degree in Regulatory Affairs from Johns Hopkins, makes her a highly strategic partner for medtech companies seeking to navigate the FDA's 510(k) pathway and enter the North American market.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
Share a brief overview of your device and timeline. Cruxi will forward your request to Sravanthi Polavarapu and help structure next steps.
Contact Now