Regulatory Specialist, Beauty & Wellness

Health & Home USA•Marlborough, MA

11d•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

High School Degree.
5+ years of experience in consumer relation’s complaint handling or 2+ years of experience in regulatory adverse event reporting of medical devices and/or consumer electronics.
Exposure to regulatory processes and software to facilitate compliance.
Ability to understand and interpret regulatory standards, such as medical device regulations (FDA, MDR, etc) and CPSC related and/similar regulations.
Good understanding of consumer relations call center workflows.
Authorized to work in the United States on a full-time basis.

Nice To Haves

Associates or Bachelor’s Degree.

Responsibilities

Support in the coordination of effective regulatory strategies for Beauty & Wellness products, including ensuring we consistently meet applicable regulations across our global operations in regard to coordinating on the complaints and adverse event reporting process for all Medical and Wellness products.
Review all customer calls with a claim of a personal injury or property damage to determine if the adverse event needs to be reported to a regulatory body such as the FDA or CPSC.
Determine if and potential adverse events/adverse events require a field action or CAPA to be taken on any given product line.
Coordinate the adverse event reporting process required to the respective regulatory agencies and brand licensors in the US in a timely manner for the Wellness products, both under the FDA and CPSC oversight.
Work with relevant international regulatory team members in Europe and Asia Pacific regions to determine if international adverse events shall be reported to the FDA.
Manage the complaint investigation by driving and maintaining the individual complaint files for those complaints that need an investigation.
Ensure that trend review, returns review and any other investigations are completed.
Ensure complaint product is received and investigated through the complaint lab and the complaint is closed after investigation.
Assist in maintaining all SOPs and work instructions related to complaint management.
Perform other regulatory tasks as assigned including support FDA, ISO, other third-party audits; and any other internal audits related to complaints management, and regulatory related matters.