Regulatory Specialist

5 days ago

Hudson, United States BOXOUT® Full time

Company Description

BOXOUT, LLC is a family-owned national distributor of rehabilitation, chiropractic, fitness, spa, massage, beauty, and health & wellness products based in Hudson, OH. With a focus on servicing consumer, professional, and business-to-business markets, we uphold high distribution standards for the hundreds of manufacturers we represent. Our culture, distribution expertise, and logistics capabilities enable us to meet the diverse needs of our customers and tackle complex challenges in the health and wellness industry.


Role Description

This is a full-time on-site role as a Regulatory Specialist at BOXOUT® in Hudson, OH. The Regulatory Specialist will be responsible for ensuring regulatory compliance, analyzing regulatory requirements, and taking the lead on managing regulatory affairs. Also responsible for all pharmaceutical and medical device distribution license renewals and new applications needed to operate the business. Strong communication skills and analytical abilities are key to success in this role.


You will perform duties as assigned by your manager who will assist in training, prioritizing work, and clarifying responsibilities. Qualified candidates must be able to multi-task with a sense of urgency while maintaining attention to detail. Excellent communication and tracking skills are required for this role. This job necessarily requires one to be accurate, thorough, and to ask questions.


Qualifications

  • Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs
  • Analytical Skills and Communication
  • Experience in interpreting and applying regulatory standards
  • Detail-oriented with strong organizational skills
  • Ability to collaborate effectively with cross-functional teams
  • Knowledge of FDA regulations and industry guidelines
  • Bachelor's degree in a related field (e.g., Regulatory Affairs, Health Sciences)
  • Certification in Regulatory Affairs is a plus


Responsibilities

  • Effectively manage all pharmaceutical and medical device distribution licenses needed to operate the business.
  • Engage Boards of Pharmacy throughout the US to complete renewals and new license applications.
  • Assist in internal auditing to ensure compliance with all federal, state, and local regulations.
  • Assist in external audits including NABP, FDA, and Boards of Pharmacy.
  • Assist in assessing dietary supplement as meeting legal requirements (DSHEA).
  • Ensure regulatory compliance with FDA, Health Canada, Medical Device licensure.
  • Identify and communicate improvement opportunities.
  • Assist in researching Medical Devices, Device Classes, and whether devices are OTC or Rx only.
  • Help to navigate regulatory differences and needs between states for Wholesaler permits, DME licenses, Rx prescribing, CBD regulations, etc.
  • Help the team identify issues by thinking independently


Experience in Regulatory Affairs, Quality Assurance, Wholesale Distribution or Project Management is preferable. Knowledge of FDA and Health Canada regulations are a plus. At least 2 years’ experience in a similar role as described is desired (looking for skill set more than job title).

 

Benefits

  • Comprehensive benefits package including Medical, Dental, etc.
  • Quarterly bonus potential
  • Career path planning and growth opportunities
  • And much more


Salary consummate with experience.

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