Senior Regulatory Specialist

Position: Sr. Regulatory Specialist

Department: Regulatory for Wellness

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 role will be reporting to theSenior Manager ofRegulatory & ClinicalAffairs. The successful candidate willsupport inthecoordination ofregulatory guidance and filingsformedical devices, wellness devices, wearables, and mobile applications worldwide.

• Manage the regulatory affairs activities associated with development and revision of labeling, advertising and promotional and scientific materials and publications for marketed products in support of the assigned product categories. This will be specifically related to FDA, EPA, FTC,CPSCetc.

• Provide regulatory support andexpertiseto product development teams to ensure compliance with US,Canadaand Latin America government requirements with regards to commercial and post-marketing activities.

• Maintain Helen of Troy and relevant affiliates in compliance with government requirements for the imported and distribution of products in the US,Canadaand Latin America. (e.g., permits, licenses, registrations, and labeling).

• Review Engineering Change Requests (ECR) and make assessmentsas toifchanges to products are considered significant or not.

• Work closely with Europe and Asia regulatory affair managers to provide and obtain the required documentation for product registrations in different global regions.

• Compile andsubmittraditional and/or special 510ks through the FDAs online database.

• Support in the maintenance of ISO 13485 and ISO9001 compliance and procedures and the Helen of Troy Standard Operating Procedures.

• Serve as the Helen of Troy contact person for regulatory agencies.

Skills needed to be successful in this role:

• Understanding of ISO 13485 and ISO 9001forquality managementrequirements.

• Ability to understand and interpret regulatory standards.

• Ability to communicate with external agencies such as the Federal Drug Administration.

• Strong attention to detail.

• Track and maintain registration periods to meet registration dates and follow-ups for completeness for a large group of registration.

• Excellent verbal and written communication skills.

• Flexibility to managemultiple projects for multiple internal customers.

• Competence in Microsoft Office Suite, notably, Excel, Word, and PowerPoint.

Minimum Qualifications:

• Bachelorsdegree in arelevant field.

• 4+years of experience inregulatorymedical devices.

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

Preferred Qualifications:

• Regulatory Affairs Certificationfor Medical Devices.

In Massachusetts, the standard base pay range for this role is $88,743 - 110,929 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 youre 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 , and .

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.