Skilled in FDA’s quality system regulations. Worked as an FDA investigator and medical device specialist for over 10 years, conducting audits in the U.S. and internationally (Europe, China, India, Japan, Taiwan). Engaged in training and supervising FDA investigators and served as a subject matter expert, mentor, and presenter for FDA’s National New Hire Training courses. Collaborated with industry and foreign regulators regarding FDA’s inspectional process. Master’s Degree in Mechanical Engineering. Knowledge in assisting companies comply with various regulatory requirements including reporting recalls, reporting adverse events, design control requirements, corrective and preventive action requirements, and production and process requirements.Offering FDA consulting services including: • Conducting audits/mock FDA inspections to ensure compliance with FDA regulations• Pre-approval, pre-market, and post-market audits• Support during FDA inspections• Assisting with 483 responses and Warning Letter remediation• Quality System and FDA inspection readiness trainingFor services with me at Conscious Consulting Solutions LLC, please contact me by messaging me on LinkedIn, emailing me at Seema@CCSolns.com, filling out the contact form at www.ccsolns.com, or calling/messaging me at (650) 418-0512.