Regulatory Specialist, Medical Devices

Health & Home USA•Marlborough, MA

18h•$70,000 - $90,000•Hybrid

About The Position

Our Beauty & Wellness division empowers consumers with trusted products that support self-care, from salon-quality styling tools to wellness devices like humidifiers and air purifiers. Our innovative products and solutions promote healthy living, elevating the lives of consumers every day. This business unit includes Braun, PUR , Honeywell , Vicks , Hot Tools , Drybar , and Revlon brands, and this role may support one or more of these brands. Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better. We are powered by knowledgeable, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent! 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. What you will be doing: 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.

Requirements

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 is critical.
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.
Bachelor’s degree or equivalent experience or - 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.

Nice To Haves

Foreign language proficiency (e.g., Spanish, Chinese, French)

Responsibilities

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 Postmarket Surveillance activities by collecting, organizing, and analyzing postmarket data such as complaints, customer feedback, and trends.