The Regulatory Compliance Coordinator ensures compliance documents satisfy federal, state, and local government requirements. Coordinates the preparation and completion of regulatory and compliance documents. Being a Regulatory Compliance Coordinator requires a bachelor’s degree. May assist in the implementation and monitoring of compliance controls, compliance procedures and operational processes. In addition, Regulatory Compliance Coordinator typically reports to a supervisor or manager. Being a Regulatory Compliance Coordinator gains exposure to some of the complex tasks within the job function. Occasionally directed in several aspects of the work. Working as a Regulatory Compliance Coordinator typically requires 2 to 4 years of related experience.
Regulatory Compliance Coordinator Job Description Template
Our company is looking for a Regulatory Compliance Coordinator to join our team.
Responsibilities:
- Document, follow-up on, and close product complaints as reported from various sources;
- Work from verbal and/or written instructions;
- Complete complaint investigations and MDR/MDV reports within internal and regulatory timelines;
- Document, follow-up on, and close product field actions as required;
- Work with engineering groups to ensure product investigation is complete and accurate;
- Develop and maintain positive relationships with regulatory agencies through professional oral and written communications;
- Review complaints for potentially reportable adverse event status, including evaluation and follow-up regarding MDR/MDV reporting;
- Review complaint records prior to closure to ensure records are compliant with all relevant regulatory requirements;
- Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions;
- Work with other departments on known and emerging issues to make quality improvements.
Requirements:
- Prepares and/or completes organization, department and/or processor reports to provide timely and accurate information;
- Reviews donor charts (as assigned) for accuracy and completeness to ensure compliance with regulatory requirements, internal policies and procedures;
- Proficient in Microsoft Office (Word, Excel or Access, PowerPoint);
- Must be able to communicate effectively (verbal and written) with high customer service;
- Previous work experience in regulated industry preferred;
- Strong detail orientation and ability to meet deadlines. Planning and organization skills a must.