Senior Regulatory Specialist

Our Beauty & Wellness division empowers consumers with trusted products that support self‑care, from salon‑quality styling tools to wellness devices such as humidifiers and air purifiers. The division encompasses brands including Braun, PUR, Honeywell, Vicks, Hot Tools, Drybar, Curlsmith, and Revlon. Role Overview Senior Regulatory Specialist reporting to the Senior Manager of Regulatory & Clinical Affairs. The role supports the coordination of regulatory guidance and filings for medical devices, wellness devices, wearables, and mobile applications worldwide. Responsibilities Coordinate regulatory guidance and filings for medical devices, wellness devices, wearables, and mobile applications worldwide. Manage regulatory affairs for labeling, advertising, promotional and scientific materials and publications for marketed products across assigned categories (FDA, EPA, FTC, CPSC, etc.). Provide regulatory support to product development teams to ensure compliance with U.S., Canada and Latin America government requirements for commercial and post‑marketing activities. Maintain compliance with import and distribution requirements in the U.S., Canada and Latin America (permits, licenses, registrations, labeling). Review Engineering Change Requests (ECR) and assess whether changes are significant. Collaborate with European and Asian regulatory managers to obtain required documentation for product registrations in those regions. Compile and submit traditional and special 510(k)s via the FDA’s online database. Support ISO 13485 and ISO 9001 compliance and procedures, and Helen of Troy Standard Operating Procedures. Serve as the primary contact for regulatory agencies. Qualifications Understanding of ISO 13485 and ISO 9001 quality management requirements. Ability to interpret regulatory standards and communicate with external agencies such as the U.S. Food and Drug Administration. Strong attention to detail. Track and maintain registration periods to meet deadlines and follow‑ups for a large portfolio of registrations. Excellent verbal and written communication skills. Flexibility to manage multiple projects for multiple internal customers. Competence in Microsoft Office Suite (Excel, Word, PowerPoint). Minimum Qualifications Bachelor’s degree in a relevant field. 4+ years of experience in regulatory medical devices. Authorized to work in the United States on a full‑time basis. Preferred Qualifications Regulatory Affairs Certification for Medical Devices. Hybrid Work Schedule Hybrid model with in‑office collaboration from Tuesday through Thursday, and optional remote work on Mondays and Fridays, subject to business needs. Benefits Competitive salary and bonus structure. Health, dental & vision insurance. Paid holidays, paid parental leave, and paid time off. 401(k) with company match. Basic life insurance, short‑term disability, and long‑term disability. Paid charitable leave and educational assistance. Equal Opportunity/Affirmative Action Employer Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences, thoughts, cultures, and backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. We will provide individuals with disabilities with reasonable accommodations to participate in the job application process. If you would like to request an accommodation, please contact Human Resources at View phone number on click.appcast.io. #J-18808-Ljbffr