Regulatory Specialist, Beauty & Wellness

About the role

The Regulatory Specialist will support in the coordination of effective regulatory strategies for Beauty & Wellness products, including ensuring consistent compliance with applicable regulations across global operations. This role will focus on complaints and adverse event reporting for all Medical and Wellness products.

Responsibilities

• 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.
• Carefully 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.
• Avoidance of 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.

Requirements

• Familiarity with complaint handling processes and regulated reporting requirements across global regions.
• Strong attention to detail.
• Excellent verbal and written communication skills.

Qualifications

• 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.

Skills

• Familiarity with complaint handling processes and regulated reporting requirements across global regions.
• Strong attention to detail.
• Excellent verbal and written communication skills.

Pay

The standard base pay range for this role is $70,447.68 - 88,059.59 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.

Schedule

This role is offered on a hybrid schedule, working 3 days onsite in Marlborough, MA. The 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.