Senior Regulatory Specialist

Health & Home USA•Marlborough, MA

1d•Hybrid

About The Position

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!

Requirements

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.
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.

Nice To Haves

Regulatory Affairs Certification for Medical Devices.

Responsibilities

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.
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 510k’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.