Healthcare Regulatory Compliance
GEMCORE’s continued success has earned us national recognition with Inc. Magazine’s list of America’s Fastest-Growing Companies and with the Cleveland Plain Dealer as Top Workplace 6 years running! We are looking for qualified candidates who share our enthusiasm and drive for winning and want to be part of our caring culture!
Are you looking for a role that is part of a key initiative that is vital for the growth of the organization? All the while allowing for work/life balance? Edwards Health Care Services, Inc., a division of GEMCORE is a well-established and growing healthcare distribution company specializing in highly efficient distribution through its nationwide wholesale, retail, and pharmacy divisions. We are seeking a highly motivated Healthcare Regulatory Compliance person to join our high energy, friendly team. The Regulatory Compliance’s main responsibility is to assist in the successful administration of the Corporate Compliance Program. This role is vital in working closely with our growing Pharmacy in ensuring compliance with outside accrediting organizations, as well as state/federal licensing organizations.
We offer growth opportunities with potential for advancement
This position is an in-office position located in Hudson, OH
Schedule is 8:15 am - 5:00 pm, Monday through Friday
Employer paid vacation
Benefits available included medical/dental/vision, life, short and long-term disability insurances, and 401K Retirement Savings Plan
Ongoing training and development
Key Responsibilities:
Research federal and state regulatory requirements for the distribution of medical devices.
Process state and federal license applications to ensure medical device license requirements compliance.
Assists in the implementation and monitoring of compliance controls, compliance procedures and operational processes.
Conducts timely filings of reporting and renewal activity with licensing and regulatory agencies for Wholesale Distributor, DME and Pharmacy.
Maintain database and create electronic records of company contracts, licenses and agreements.
Inquires and responds to designated regulatory and accreditation agencies.
Maintains working knowledge of basic healthcare compliance legal and regulatory requirements.
Research regulatory changes that impact standard operating procedures and standards.
Be knowledgeable of the agencies, such as the state Pharmacy Boards, Departments of Health, Secretary of State offices, Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), and USPTO, that issue the licenses and credentials maintained by the company.
Key requirements:
High attention to detail and excellent organizational skills
Strong reading comprehension ability
Qualified candidates must have excellent written, and verbal communication skills.
Demonstrated strong computer skills.
Knowledge of Process Improvement concepts.
Minimum 0-2 years of related experience in a consumer service or healthcare environment.
Ability to multi-task with established time management skills.
Bachelors’ degree or equivalent experience.
About GEMCORE
GEMCORE, a family of companies headquartered in Hudson, Ohio - Edwards Health Care Services, GEMCO Medical, GemCare Wellness, and GEM Edwards Pharmacy - offers a core set of healthcare solutions by partnering with manufacturers, providers, employer groups, insurance groups, and patients to deliver high quality healthcare products and innovative services to proactively better lives. For more information, visit www.gemcorehealth.com.
To learn more about this position and to view other openings, visit our career site: https://www.gemcorehealth.com/careers/