Director, Regulatory Affairs

Join our Legal team at Helen of Troy and make an immediate impact on our trusted brands: OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, Revlon and Olive & June. Together, we build innovative and useful products that elevate people's lives everywhere every day. 

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: Director – Regulatory & Clinical Affairs  

Department: Legal 

Work Location: Marlborough, MA, Hybrid (work 3 days onsite) 

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: 

The Director of Regulatory & Clinical Affairs is responsible for developing and executing regulatory strategies and clinical strategies to ensure timely market access for Helen of Troy’s segment portfolio of consumer medical devices (Class I & II) and consumer products subject to CPSC oversight. This individual will lead a team of regulatory and clinical professionals, partner cross-functionally to ensure compliance throughout the products’ lifecycle, aligning resources and fostering a culture of excellence, integrity, and collaboration. You will report to the Vice President of Regulatory, Sustainability & Governance, who oversees global product and packaging regulatory affairs.  

• Develop and implement regulatory strategies for new product development, global market clearances, and product lifecycle management for consumer medical devices (Class I & II) and consumer products subject to CPSC oversight.  

• Oversee regulatory filings, including 510(k)s, Technical Files, and international registrations.  

• Ensure compliance with global regulatory requirements from agencies such as the FDA, Health Canada, and the European Union's MDR, as well as with standards from organizations like CPSC, FCC, and EPA where applicable. Build and maintain effective working relationships with regulatory authorities and industry trade groups.   

• Provide regulatory guidance on labeling, packaging, and marketing materials to ensure consistency and compliance.  

• Collaborate with divisional Quality and R&D teams to review and approve changes to product design, manufacturing, and quality systems.  

• Support product design and development through regulatory planning and risk assessments.  

• Manage global regulatory intelligence, communicating key changes to internal teams.  

• Provide regulatory input for clinical evaluations, human factors studies, and post-market surveillance activities.  

• Serve as a lead on product crisis response teams for recalls, field actions, and reportable events.  

• Establish and improve regulatory processes, systems, and Standard Operating Procedures (SOPs).  

• Oversee the Quality Management System and audits, including MDSAP and ISO-9001 and other regulat