Provided Regulatory Affairs leadership and guidance for new product development in the diabetes management class II and class III devices, and health & wellness software products. Provided assistance to the R&D and other departments in the development of processes to meet FDA and international standards requirements. Conducted successful external and internal audits to ensure continued compliance to FDA and ISO 13485 requirements. Managed the Quality Management System including CAPA, audits, document control, training, calibration, equipment handling, and management reports.

Rebuilt the Regulatory Affairs department, so that they were successful in the submission and approval/clearance of cosmetic and medical devices with the FDA and international government regulatory agencies. Through this leadership, the RA team was responsible for domestic and international registrations, review of marketing materials and labeling changes, and supporting the release of new products throughout the world. Also lead the RA team in the registration updates required for the site change for HydraFacial in 2020.

Led Regulatory Affairs department in the submission and approval/clearance of medical devices and disinfection products with the FDA, EPA and international government regulatory agencies. Reviewed marketing materials and labeling changes to ensure that these meet the compliance requirements for the regions where the products are registered, marketed and sold. Launched and led cross departmental projects to ensure the continued compliance of existing products with the release and implementation of new regulations worldwide.

Ensure that Regulatory Affairs requirements are integrated into the New Product Development projects. Completed project to review, streamline, and revise the Accelerated Product Development process at Kerr, eliminated 24% of the forms and 16% of the redundant activities for new product development projects.

Responsible for ensuring that products produced and distributed by Advanced Sterilization Products are compliant to various Product Stewardship regulations and laws, including the Restriction of Hazardous Substances for Electrical and Electronic Equipment Directive (RoHS), Waste Electronic and Electronic Equipment Directive (WEEE), Registration Evaluation Authorization and Restriction of Chemicals (REACH), Biocidal Products Directive (BPR), and other regulations.

Responsible for regulatory approval of medical devices in the United States and around the world.

Business consultant for pharmaceutical, medical device, and healthcare industry

Performed regulatory registration activities for a Class III active implantable medical device to get approval for this product worldwide.

Provide sales and technical support for implanted medical devices for doctors, sales representatives, and patients.

Coordinated and tested helmets and headgear to DOT, CPSC, and other government standards as an independent laboratory for headgear manufacturers. Performed investigations and replication testing for accident cases as an expert witness.