Senior Regulatory Specialist

helenoftroy; Marlborough (MA); Hybrid; USD 89,000 - 111,000; Full time

Benefits offered by this job

Salary + Bonus

Healthcare

Dental

Vision

Paid Holidays

Paid Parental Leave

401(k) with company match

Basic Life Insurance

Short Term Disability

Long Term Disability

Paid Time Off

Paid Charitable Leave

Educational Assistance

Job summary

Helen of Troy seeks a Sr. Regulatory Specialist – Regulatory for Wellness in Marlborough, MA. The role supports labeling, advertising and scientific materials for US, Canada and Latin America with a hybrid schedule (Tue–Thu in office, Mon/ Fri remote).

You will collaborate with product teams, interact with FDA and other agencies, and maintain ISO 13485/ISO 9001 compliance while coordinating global product registrations and registrations for multiple brands.

Qualifications

• Understanding of ISO 13485 and ISO 9001 quality management requirements.
• Ability to understand and interpret regulatory standards.
• Ability to communicate with external agencies such as the FDA.

Responsibilities

• Manage regulatory affairs activities related to labeling, advertising, and materials compliant with US, Canada and Latin America regulations.
• Provide regulatory support to product development teams to ensure post-marketing compliance.
• Maintain compliance for importation and distribution with permits, licenses, registrations, and labeling.
• Review engineering changes and assess significance for regulatory impact.
• Coordinate with regulatory managers in Europe and Asia to obtain required documentation.

Skills

ISO 13485

ISO 9001

Regulatory standards

FDA communications

Attention to detail

Registration tracking

Education

Bachelor's degree in a relevant field

Tools

Microsoft Office

Job description

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 , Curlsmith , 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!

Sr. Regulatory Specialist – Regulatory for Wellness

Marlborough, MA – Hybrid (3 days onsite)

Work Schedule

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.

Responsibilities

The role will be reporting to theSenior Manager ofRegulatory &ClinicalAffairs.

• 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 510k's through the FDA's 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.

Required skills

• 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

• Bachelor'sdegree 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
• Educational Assistance

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 [phone].

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.