Regulatory Specialist, Medical Devices

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.

• 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.

• Support cross functional investigations by maintaining project trackers and maintaining schedules

• Work with Engineering, Quality, and Marketing to support new and sustaining projects

Skills needed to be successful in this role:

• 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.

Minimum Qualifications:

• 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. 

Preferred Qualification:

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

In Massachusetts, the standard base pay range for this role is $70,000 - $90,000 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. 

#li-ab1

#LI-HYBRID

For more information about Helen of Troy, visit www.helenoftroy.com. 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.