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.   

• Establish and continuously improve regulatory processes, systems, and SOPs.  

• Responsible for Quality Management System, oversight of audits including MDSAP, ISO-9001, and other regulatory audits.  

• Manage the Document Control group to ensure compliant documentation practices and timely document lifecycle management.   

• Lead, mentor, and grow a high-performing Regulatory Affairs team, including internal staff and external consultants.  

• Provide coaching, performance evaluations, and career development support.  

• Align resources and priorities to ensure timely execution of global regulatory deliverables.  

• Foster a culture of compliance, accountability, and continuous improvement. 

Skills needed to be successful in this role: 

• In-depth understanding of medical device regulatory pathways (Class I & II), labeling regulations, and advertising/promotional requirements.  

• Working knowledge of global regulatory systems, including EU MDR, ISO 13485, and CPSC regulations.  

• Ability to write and review technical documents and regulatory submissions with precision and clarity.  

• Skilled in negotiation, project management, and cross-functional leadership.  

Minimum Qualifications: 

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific discipline 

• Lead, mentor, and grow a high-performing Regulatory Affairs team, including internal staff and external consultants

• Provide coaching, performance evaluations, and career development support

• Align resources and priorities to ensure timely execution of global regulatory deliverables

• Foster a culture of compliance, accountability, and continuous improvement

• Authorized to work in the United States on a full-time basis 

Preferred Qualifications: 

• Advanced degree (MS, PhD, MBA, or RAC certification)

• Proficient in Microsoft Office and regulatory management tools; experience with electronic document management systems (EDMS)

In Massachusetts, the standard base pay range for this role is $ 152,091.25 - $228,136.87 annually. This base pay range is specific to Massachusetts and may not be applicable to other locations. Actual salaries will vary based on several factors, including but not limited to location, experience, skill level, and performance. The range listed is just one component of the total compensation package for employees.  

Benefits: Salary + Bonus, Healthcare, 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, and Educational Assistance. 

Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you. 

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