Licensing and Compliance Specialist
SUMMARY
The Licensing and Compliance Specialist plays a vital role in ensuring the highest quality and safety standards of the medical devices and pharmaceutical products North American Rescue, LLC and NAR Medical Depot, LLC manufacture and sell. The Licensing Manager must possess strong organizational skills to ensure records are maintained, licenses do not lapse, and requirements are satisfied. The Licensing Manager will collaborate closely with various departments to ensure compliance and streamline operations.
ESSENTIAL RESPONSIBILITIES
• Obtain and maintain state licenses, ensuring compliance with state regulations, and handling renewals.
• Maintain Drug Enforcement Administration (DEA) registration and state-controlled substance licenses, including managing DEA and state audits.
• Submit monthly, quarterly, and annual state and federal reports as required by regulatory agencies for the distribution of prescription drugs.
• Maintain the National Association of Boards of Pharmacy (NABP) Drug Distributor accreditation, including monitoring requirements, ensuring compliance, and managing audits.
• Prepare and submit federal and state Sunshine Act reports.
• Verify National Provider Identifiers (NPIs) for Customers.
• Maintain U.S. Food and Drug Administration registrations and communicate with the FDA, including the Office of Blood Research and Review Compliance. Oversee market communications, withdrawals, and recalls.
• Support the Quality Management System (QMS) for convenience kitting and ISO 13485 Compliance.
• Continuously monitor changes in licensing regulations and requirements and promptly update company policies to ensure ongoing compliance.
SUPPLEMENTAL RESPONSIBILITIES
• Assist the General Counsel and Director of Quality Assurance & Regulatory Affairs to ensure compliance with legal and regulatory requirements.
• Other duties as assigned
AUTHORITY
• Functions as subject matter expert for licensing and registrations
ACCOUNTABILITY
• Ensure all registrations, certifications, and licenses remain current and in good standing
• Help ensure operational compliance with SOPs
• Ensure timely regulatory reporting
• Be present to lead audits from outside agencies
• Ensure completion of action steps from inspections, audits, and CAPA
QUALIFICATIONS
Education
• Bachelor’s degree and 3 years of experience in licensing management within the medical device and pharmaceutical industry, or 7 years of experience in licensing management within the medical device and pharmaceutical industry.
Competency and Skills
• Licensed and authorized Designated Representative for distribution of pharmaceuticals and medical devices
• Strong knowledge of licensing regulations and compliance requirements
• Excellent organizational, management, and multitasking skills
• Exceptional communication and interpersonal abilities
• Attention to detail and a proactive approach to problem-solving
• Efficiency with MS Office suite
• Able to successfully complete a drug and background check
Experience
• Appropriate combination of education and experience based on requirements under Education Qualifications
Specific Characteristics
• Must be able to pass all background check and licensing requirements as set forth by the licensing agencies (e.g., State boards of pharmacy, DEA, etc.)
DEMANDS
Time and Availability
• Must be able to work a minimum of 40 hours each week, generally from 8am-5pm
• Must be able to work extended hours and overtime on normal workdays and/or weekends as needed and demanded by job duties
Travel
• Must have transportation to and from headquarters and can travel out of state up to two weeks per year
Physical
The physical demands described here are representative of those that must be met by a typical office employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Frequently required to hear and talk
• Use of hands for keyboard usage
• Frequent sitting, standing and walking
• Occasional reaching with hands and arms, stooping, kneeling, and lifting and/or moving up to 30lbs
Environment
• Must be able to work in a moderately loud work environment
DISCLAIMERS
AAP/EEO Statement
North American Rescue provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.
Medical Equipment Manufacturing
Legal
Full-time