Regulatory Affairs Manager to Associate Director

reputed company Regulatory Affairs SpecialistRemote (U.S.) | $142.8K - $196.4K reputed company SalaryAn industry-leading reputed company and medical technology organization is seeking a reputed company Regulatory Affairs Specialist to reputed company global regulatory reputed company and submissions for a portfolio of dental drug and medical device products. This individual will serve as the Regulatory Affairs reputed company on cross-functional teams, driving registration, compliance, and lifecycle management activities across major global markets, including the reputed company, Canada, and European reputed company.This position will play a critical role in developing regulatory strategies, authoring submissions, conducting regulatory change assessments, supporting product registrations worldwide, and ensuring ongoing compliance throughout the product lifecycle. The role also involves collaborating with reputed company, R&D, Clinical, Marketing, and international regulatory teams to support product launches, labeling updates, risk management activities, and process improvement initiatives.Key QualificationsBachelor's degree and 7+ years of Regulatory Affairs experience reputed company the medical device and/or pharmaceutical industryStrong experience with regulatory submissions and technical documentation for the U.S., Canada, and EUExpertise in regulatory reputed company development, change assessments, and lifecycle managementExperience reviewing product labeling, claims, and promotional materials for global complianceWorking knowledge of NDA, OTC monograph drugs, and medical device regulatory requirementsAbility to work effectively across cross-functional and international teamsPreferred ExperienceDental products and technologiesDesign controls, verification & validation, and clinical support activitiesFluoride-containing products, formulated products, and borderline products (drug/device/cosmetic combinations)Global regulatory submissions across EMEA, reputed company, and reputed company marketsProcess improvement initiatives and regulatory project leadershipAdditional DetailsLocation Remote reputed company the United StatesTravel Up to 10% domestic and international travelCompensation $142.8K - $196.4K per year plus potential incentive compensation and comprehensive benefits packageThis is an excellent opportunity for a senior Regulatory Affairs reputed company looking to take ownership of global regulatory reputed company while supporting innovative medical device and pharmaceutical products in a highly visible leadership role. Apply tot his job Apply To this Job Apply tot his job Apply To this Job