Regulatory Specialist - Sarnova - Dublin, Ohio at Sarnova – Dublin, Ohio

Position Title: Regulatory Specialist - Sarnova - Dublin, Ohio

Req ID: 5292

Location: Dublin, Ohio

Remote: Hybrid

Job Description Overview

The Regulatory Specialist will be responsible for establishing and maintaining compliance with the VAWD, DEA & FDA process including distribution licensing as well as other responsibilities as assigned.

Hybrid Schedule: M-Th in office, Fri work from home

Sarnova is the leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets and is the industry leader in Revenue Cycle Management within Emergency Medical Services (EMS). The company operates through several market-leading companies including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, EMP and Cardio Partners, a full Sudden Cardiac Arrest Solution provider, and Digitech, the leader in EMS revenue cycle management.

Responsibilities

Summary:

The Regulatory Specialist will be responsible for establishing and maintaining compliance with the VAWD, DEA & FDA process including distribution licensing as well as other responsibilities as assigned.

Essential Duties and Responsibilities:

• Manage FDA, DEA, and state board of pharmacy licensing processes.
• Renew applicable licenses for all subsidiaries.
• Responsible for all aspects of NABP application, accreditation & renewal activities.
• Draft Work Instruction for the NABP accreditation process.
• Support operations with costs and timeframes to license appropriate warehouses for desired shipping models.
• Prepare warehouses for audit/inspections.
• Perform audits throughout the business in accordance with our compliance program.
• Collaborate with operations to develop and implement processes to fill gaps identified in audit findings, and law changes.
• Serve as back up to assist in the regulatory activities for corporate acquisitions.
• Assist in managing the company’s suspicious order monitoring program.
• Prepare annual budget for licensing expenses and perform analysis periodically to report and reconcile any surplus or deficit.
• Process department credit card transactions.

Skills/Experience Required:

• Bachelor’s degree.
• 2 to 5 years of quality or regulatory experience in the medical device or pharmaceutical industry.
• Direct experience in the medical device or pharmaceutical industry desired.
• Demonstrated familiarity with FDA, DEA and state regulations and the application of sound Quality Systems to ensure compliance.
• Strong individual accountability and ethics: acts with integrity and takes ownership for attitude, behavior and outcomes.
• Ability to interact and communicate professionally and effectively with internal and external customers including regulatory agencies.
• Strong written and verbal communication skills.
• Well-developed organizational and cross functional skills.
• Computer skills to include Microsoft Office applications, with emphasis in database and spreadsheet software.

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients’ lives. Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day. We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.