Clinical Specialist, Wellness

Health & Home USA•Marlborough, MA

2d•$80,000 - $95,000•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 Position: Clinical Specialist, Wellness Department: Regulatory  for Braun & Vicks Work Location: Marlborough, MA 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.

Requirements

Understanding of ISO 14155 for clinical requirements
Ability to understand and interpret regulatory standard
Ability to analyze and interpret clinical data and draw conclusions
Strong attention to detail
Excellent verbal and written communication skills
Flexibility to manage multiple projects for multiple internal customers
Proficient in Microsoft Office Suite, notably, Excel, Word, and PowerPoint
Associates degree in a relevant field
2 + years of experience in regulatory or clinical affairs of medical devices
Authorized to work in the United States on a full-time basis

Nice To Haves

Bachelor’s degree in a relevant field

Responsibilities

The role will be reporting to the Senior Manager of Regulatory & Clinical Affairs. The successful candidate will support in the coordination of the clinical trials for products such as thermometers and blood pressure monitors, as well as prepare documentation for clinical protocols and reports to support regulatory submissions of products in the HELE portfolio.
Work with principal investigators at clinical sites to drive clinicals forward to ensure clinical data is collected as scheduled.
Collect and analyze clinical data from clinical sites as received by the clinicians on Clinical Report Forms.
Author clinical study protocols with input from clinical experts, the internal HELE cross functional teams and biostatisticians.
Submit clinical protocols and any accompanying clinical site-specific documentation for IRB and/or Ethics Boards to receive clearance to begin clinicals.
Report any preliminary clinical data findings to the cross-functional team members, including number of patients recruited number and/or groups of patients yet to be recruited, and any preliminary clinical data results per the study's endpoints.
Summarize final clinical results into clinical study reports to be used for global regulatory submissions.
Author Clinical Evaluation Plans and Clinical Evaluation Reports to support regulatory submissions.
Support any clinical portions of Post Market Surveillance Plans/Reports and Post Market Clinical Follow-up Reports as necessary.
Conduct Literature Reviews to support CERs and marketing claims for different product lines.
Work with cross-functional team members to create critical tasks for usability studies.
Execute usability studies per international standards.
Perform other regulatory or administrative tasks as assigned including support FDA, ISO, other third-party audits; and any other internal audits related to clinical affairs and regulatory related matters.