Regulatory Affairs Manager to Associate Director

reputed company Regulatory Affairs Specialist Remote (U.S.) | $142.8K - $196.4K reputed company Salary An 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 Qualifications • Bachelor's degree and 7+ years of Regulatory Affairs experience reputed company the medical device and/or pharmaceutical industry • Strong experience with regulatory submissions and technical documentation for the U.S., Canada, and EU • Expertise in regulatory reputed company development, change assessments, and lifecycle management • Experience reviewing product labeling, claims, and promotional materials for global compliance • Working knowledge of NDA, OTC monograph drugs, and medical device regulatory requirements • Ability to work effectively across cross-functional and international teams Preferred Experience • Dental products and technologies • Design controls, verification & validation, and clinical support activities • Fluoride-containing products, formulated products, and borderline products (drug/device/cosmetic combinations) • Global regulatory submissions across EMEA, reputed company, and LATAM markets • Process improvement initiatives and regulatory project leadership Additional Details • Location: Remote reputed company the reputed company • Travel: Up to 10% domestic and international travel • Compensation: $142.8K - $196.4K per year plus potential incentive compensation and comprehensive benefits package This 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