Job Description

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 – Regulator y & 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 regulatory audits, including directing the Document Control group to ensure compliant documentation practices and timely lifecycle management. Lead on clinical strategy, including the planning and execution of clinical trials to support product development and regulatory submissions. Manage the Document Control group to ensure compliant documentation practices and timely document lifecycle management . 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. Proficient in Microsoft Office and regulatory management tools; experience with electronic document management systems (EDMS) is a plus. Minimum Qualifications: Bachelor’s degree in Engineering , Life Sciences, Regulatory Affairs, or a related scientific discipline . 10+ years of progressive experience in Regulatory and Clinical Affairs within a regulated industry (medical devices and consumer products subject to CPSC). 5+ years in a people management or leadership role with demonstrated success in building and developing teams. Proven track record with global regulatory submissions including FDA 510(k), Technical Files, and international market clearances. Experience interfacing with regulatory authorities and managing audits or inspections. Experience supporting advertising, promotional review, and clinical evaluation strategies. Approximately 10 –20% domestic and international travel. Although reporting to the Marlborough office, expected to visit the Boston office once a month . Authorized to work in the United States on a full-time basis. Preferred Qualifications: Advanced degree (MS, PhD, MBA, or RAC certification) . In Massachusetts, the standard base pay range for this role is $ 140,825.23 - $ 211,237.85 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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For more information about Helen of Troy, visit . You can also find us on LinkedIn , and Glassdoor . 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 the differences in our 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 (915) 225-8000. Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, Revlon, and Olive & June – many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity. At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time. #J-18808-Ljbffr Helen of Troy

Job Tags

Full time, Temporary work, Work at office, Local area, Immediate start, Remote work, Worldwide, Monday to Friday, Flexible hours,

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