Hardworking professional having experience as a Sr. Regulatory Affairs Specialist and Formulation Scientist with record of success in formulation development, process development, experienced in Quality Assurance, change controls, Deviations, regulatory submissions and Post Market Surveillance activities and process optimization developing and implementing regulatory strategies for compliance with FDA regulations and CMC requirements. Expertise: Hands-on expertise in 510(k) documentation and submissions to the FDA and other regulatory authorities. Strong background in regulatory strategy, dossier/submission writing, regulatory gap assessment, risk mitigation, and documentation. Strong understanding of FDA 21CFR (part 11, 820) requirements, QSR, MDD, EU MDR, IND – NDA, ISO 13485, ISO 14971, and other Regulatory Compliance (ICH Guidelines, CFR, ISPE, ISO, Health Canada, PMDA), CAPA, Investigation and Root Cause Analysis, , and documentation for submission to Notified bodies.
|
|
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy
Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.
By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy