Regulatory Specialist, Medical Devices

Position Regulatory Specialist, Medical Devices Department Shared Services – (Beauty and Wellness) Work Location Marlborough, MA, Hybrid Hybrid Schedule At Helen of Troy, we embrace a flexible hybrid work model designed to support collaboration and productivity. For roles eligible for hybrid work, our standard schedule includes in‑office collaboration from Tuesday through Thursday, with the option to work remotely on Mondays and Fridays. Any updates to this model will be communicated in advance. Please note that hybrid eligibility and schedules may vary based on business needs and manager expectations. Responsibilities This position supports regulatory affairs activities across the medical device lifecycle with emphasis on maintaining and improving the Quality Management System and supporting product registrations worldwide. This role requires strong organization, attention to detail, and the ability to collaborate across functions with clear communication. Assist in maintaining and improving the Quality Management System (QMS) including scheduling and coordinating the internal audit program, maintaining training matrices, and assisting with change management. Participate in the creation, revision, and review of QMS documentation. Support internal and external audits by maintaining audit schedules, communicating audit plans, maintaining audit records, and tracking actions stemming from audits. Follow up with stakeholders on audit‑related findings. Help monitor compliance with QMS processes by assisting with Management Reviews. Assist in preparing regulatory documentation to support product registrations. Help maintain regulatory databases, annual registrations, unique device identifiers, and other national and international registration requirements. Provide regulatory information for internal databases maintained by marketing, sales and customs teams. Support labeling requirements by participating in labeling and marketing claims development. Support cross‑functional investigations by maintaining project trackers and maintaining schedules. Work with Engineering, Quality, and Marketing to support new and sustaining projects. Support Post‑market Surveillance activities by collecting, organizing, and analyzing post‑market data such as complaints, customer feedback, and trends. Skills Needed Strong individual contributor with high level of professionalism. Ability to work well with data, documents, and people. Ability to rely on experience and judgment to plan and accomplish goals. Ability to build strong working relationships across a multi‑functional organization. Ability to communicate and work with internal stakeholders. Ability to communicate and work with external agencies. Results orientation, sense of urgency, sound judgment, and attention to detail. Must be flexible and able to effectively manage multiple competing priorities for multiple customers. Minimum Qualifications Bachelor’s degree or equivalent experience. 3 years’ regulatory experience, preferably in medical devices or other regulated products. Proficient PC skills (e.g. MS Office, Adobe, Oracle, Business Objects, FileMaker). Must be organized, able to handle multiple projects at once, and remain flexible and adaptable in a fast‑paced environment. Detail‑oriented finisher, quick‑learner, personable, ability to handle diversity and work with our team and suppliers in US, Europe, and other locations. Experience working in a regulated industry. Authorized to work in the United States on a full‑time basis. Preferred Qualifications Foreign language proficiency (e.g., Spanish, Chinese, French). Benefits Salary + Bonus Health Care Dental Vision Paid Holidays Paid Parental Leave 401(k) with company match Basic Life Insurance Short Term Disability (STD) Long Term Disability (LTD) Paid Time Off (PTO) Paid Charitable (volunteer) Leave Educational Assistance Equal Opportunity Statement 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 difference in 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 Helen of Troy