Regulatory Affairs and Compliance Manager

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 \n

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 licensureManage Onsite Compliance Audits and InspectionsMaintain all appropriate licenses needed to operate the businessUpdate 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 personnelAdvise Senior Management Team on new laws or regulatory requirements that will impact the businessEnsure all safety guidelines are communicated, followed and maintained throughout the business with regards to warehouse safety and general safety of all employeesManage year end activities to ensure all tasks are completed on scheduleMaintain Compliance audit database for all identified areasIdentify and communicate improvement opportunitiesMaintain documentation on product performance issues and timely resolution of complaintsLead monthly Compliance meeting with Senior Management TeamLead 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 agenciesQualified candidates can multi-task with a sense of urgencyStrong advisory and presentation skills to explain risks simply to non-legal teamsExcellent communication and cross-functional collaboration skillsExperience 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 \n

Competitive salary and performance bonuses

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Comprehensive benefits package

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Growth opportunities in a fast-growing business

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Mountain Climber program, our development track for emerging leaders

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Collaborative culture that values your voice

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Onsite fitness center

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Boxout is an equal opportunity employer.