Senior Regulatory Counsel
US-OH-Dublin
Sarnova
Req #: 4950
Type: Regular Full-Time
Overview: We are looking for a Senior Regulatory Counsel, to join the Sarnova team. Hybrid office. M&F work from home, T-Th office based. 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 Senior Regulatory Counsel at Sarnova is responsible for providing legal advice on various healthcare laws, rules, and regulations impacting the products and services offered by the company. Additionally, this role involves managing other regulatory responsibilities as assigned, ensuring adherence to applicable laws and regulations. Organizational Impact: As the Senior Counsel, you will play a critical role in ensuring Sarnova's compliance with regulatory standards. Your expertise will not only ensure legal adherence but also enhance the organization's reputation as a trustworthy entity in the eyes of regulators, stakeholders, and customers. Essential Duties and Responsibilities: * Advise cross-functional teams across the business on a broad variety of healthcare regulatory issues and considerations related to legal risks * Stay up to date on relevant state and federal laws and regulations related to medical device and pharmaceutical distribution * Represent the company in FDA, DEA, state Boards of Pharmacy, and other enforcement agency audits and investigations * Manage the FDA, DEA, and state board of pharmacy licensing process by developing and implementing strategic initiatives to streamline processes, ensure timely renewals, and maintain compliance with evolving regulatory requirements * Assume full responsibility for overseeing all aspects of the VAWD application, accreditation, and renewal activities, including the development of comprehensive work instructions to guide the accreditation process and ensure adherence to VAWD standards * Manage the company's product complaint and recall process * Conduct internal investigations and audits as needed * Manage the company's suspicious order monitoring program, tracking controlled substances sales, and analyze for trends * Assign tasks, manage workloads, and provide clear direction to team members * Foster a positive work environment and resolve conflicts * Set performance goals, conduct reviews, and provide constructive feedback * Mentor and train employees to enhance their skills and career growth * Implement processes to improve productivity and compliance with regulations * Manage resources efficiently, ensuring quality standards are met * Additional job duties as assigned Skills/Experience Required: * Education: Law Degree from an accredited ABA law school * Minimum of five to eight years of experience in the legal field * Proven supervisory experience and industry-specific knowledge * Strong critical thinking, problem-solving, and analytical skills * Ability to collaborate cross-functionally (e.g., Senior Leadership, sales, marketing, IT, HR, finance, customer service, warehouse) to achieve compliance and sustainability objectives * Demonstrated ability to self-identify risks/trends and generate solutions while balancing the operational needs of a business * Ability to, concisely, and comprehensively translate and communicate complex concepts at all levels of an organization * Proven ability to draft clear and complex policies, processes, procedures * Strong research skills * Commitment to discretion and strict confidentiality of sensitive information * Strong attention to detail and accuracy * Strong interpersonal skills and the ability to resolve competing interests. * Self-motivated, goal-oriented and results-driven * Ability to adapt to changing environments and handle multiple tasks * Strong sense of ethics, confidentiality, and integrity 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.
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