Clinical Specialist, Wellness

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!

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.

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 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.

Skills needed to be successful in this role:

• 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

Minimum Qualifications:

• 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

Preferred Qualifications:

• Bachelor's degree in a relevant field

In Massachusetts, the standard base pay range for this role is $80,000 - $95,000 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.

Wondering if you should apply? Helen of Troy welcomes people as diverse as our brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you.

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For more information about Helen of Troy, visit www.helenoftroy.com. You can also find us on LinkedIn, and Glassdoor.

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 (915) 225-8000.

Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, Revlon, and Olive & June - many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity.

At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide.

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.