Senior Director, Regulatory & Clinical Affairs

Join our Engineering 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: Senior Director, Regulatory & Clinical Affairs 

Department: Regulatory & Clinical Affairs 

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 Senior Director of Regulatory & Clinical Affairs is responsible for developing and executing global regulatory strategies and clinical strategies to ensure timely market access for Helen of Troy’s portfolio of consumer medical devices (Class I & II) and consumer products subject to CPSC oversight. This individual leads the Regulatory & Clinical Affairs function and partners cross-functionally to ensure products meet applicable regulatory requirements throughout their lifecycle—from concept through commercialization and post-market support. As a senior leader, the Senior Director also plays a key role in shaping regulatory and clinical policy, ensuring compliance, and fostering a culture of excellence, integrity, and collaboration.  

• Lead and direct regulatory strategy for new product development, global market clearances/approvals, and lifecycle management.  

• Oversee preparation and submission of 510(k)s, Technical Files, international registrations, and other required regulatory filings.  

• Ensure compliance with global regulatory requirements, including FDA, Health Canada, MDR, CPSC, FCC, and EPA as applicable.  

• Provide regulatory input on labeling, packaging, claims, and advertising/promotion materials to ensure consistency and compliance.  

• Partner with Quality and R&D to review and approve changes to design, manufacturing, and quality systems.  

• Direct and support regulatory planning and risk assessments during product design and development.  

• Manage global regulatory intelligence and communicate key changes to internal stakeholders.  

• Build and maintain effective working relationships with regulatory authorities and industry trade groups.  

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

• Serve as the regulatory lead on product crisis response teams (e.g., recalls, field actions, reportable events).  

• Provide strategic leadership and operational oversight for clinical strategy, including planning, execution, and reporting of clinical trials to support product development and regulatory submissions.