Job Description

Boxout is a family-owned, national distributor of health and wellness supplies with more than 72 years of continuous success. We're committed to providing quality products and excellent service to the customers who depend on us, and our business model positions us to grow with an ever-changing health and wellness market. That growth creates real opportunities for our team, and our core values support both professional and personal development. Based in a 108,500-square-foot contemporary facility in Hudson, Ohio, we foster an energetic environment where teamwork and collaboration are encouraged. About the Role

We are looking for an experienced Regulatory Affairs and Compliance Manager to lead the strategy and execution of Boxout's compliance programs. You will track evolving laws and translate complex regulations into practical steps that help build or maintain compliance processes. You will act as an internal advisor, collaborate with cross-functional teams and ensure that Boxout stays fully prepared for inspections and compliance reviews.

What You’ll Do Ensure regulatory compliance with FDA, DSCSA, NABP, Health Canada, Medical Device and Pharmaceutical distribution licensure Manage Onsite Compliance Audits and Inspections Maintain all appropriate licenses needed to operate the business Update compliance policies and procedures as needed. Ensure that compliance manuals, policies and procedures accurately reflect current laws, rules, other regulatory requirements and management intent. Direct and manage customer and practitioner credentialing compliance. Conduct yearly HIPAA and compliance training with all personnel Advise Senior Management Team on new laws or regulatory requirements that will impact the business Ensure all safety guidelines are communicated, followed and maintained throughout the business with regards to warehouse safety and general safety of all employees Manage year end activities to ensure all tasks are completed on schedule Maintain Compliance audit database for all identified areas Identify and communicate improvement opportunities Maintain documentation on product performance issues and timely resolution of complaints Lead monthly Compliance meeting with Senior Management Team Lead projects and establish project matrices as assigned Key Requirements 5+ years of experience in a compliance role managing the medical device licensing process for State Board of Pharmacies / State Health Department agencies Qualified candidates can multi-task with a sense of urgency Strong advisory and presentation skills to explain risks simply to non-legal teams Excellent communication and cross-functional collaboration skills Experience with HIPAA, Stark Law, anti-kickback laws, and other healthcare industry laws and regulations. Knowledge of FDA cGMPs (foods) and Health Canada regulations are a plus. Why Join Us

Competitive salary and performance bonuses

Comprehensive benefits package

Growth opportunities in a fast-growing business

Mountain Climber program, our development track for emerging leaders

Collaborative culture that values your voice

Onsite fitness center

Boxout is an equal opportunity employer.

Job Tags

Full time

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