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 the Senior Manager of Regulatory & Clinical Affairs. The successful candidate will support in the coordination of regulatory guidance and filings for medical 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, CPSC, etc. Provide regulatory support and expertise to product development teams to ensure compliance with US, Canada and 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, Canada and Latin America. (e.g., permits, licenses, registrations, and labeling). Review Engineering Change Requests (ECR) and make assessments as to if changes 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 and submit traditional and/or special 510(k)s through the FDA’s online database. Support in the maintenance of ISO 13485 and ISO 9001 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 9001 for quality management requirements. 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 manage multiple projects for multiple internal customers. Competence in Microsoft Office Suite, notably, Excel, Word, and PowerPoint. Minimum Qualifications Bachelor’s degree in a relevant field. 4+ years of experience in regulatory medical devices. Authorized to work in the United States on a full-time basis. Preferred Qualifications Regulatory Affairs Certification for 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. 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 View phone number on click.appcast.io. 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