Provide strategic and tactical direction for all regulatory, clinical, product safety, design, registration and post-market surveillance activities. Provide regulatory assistance on medical devices, OTC drugs, dietary supplement, food, cosmetic and general consumer goods. Provide consulting on related US FDA topics including registration and artwork labeling and claims. Provide consulting on international regulatory requirements (e.g. U.S (FDA UDI), Europe (EU MDD/MDR), Canada, Australia). Conduct hazard and product risk assessments/reviews. Assess products for third-party mandatory safety testing and claim substantiation (e.g. cytotoxicity, skin irritation, skin sensitization, heavy metals, proposition 65, CPSC children safety test, FCC, FTC). Provide guidance, asses gaps and approve product labels and packaging for regulatory compliance.