Regulatory Affairs Coordinator

We want you to help our team save more lives! Named a Top Workplace for over 10+ years, Donor Alliance is driven by our core values, grounded in People First. Celebrating a commitment to the ideas, growth, and development of all team members in support of our mission to advance donation and transplantation efforts. With a team of bright minds united in saving and healing lives, we look forward to learning more about your unique skills and talents. Regulatory Affairs Coordinator As a Regulatory Affairs Coordinator, you would oversee the comprehensive monitoring and analysis of current and incoming regulations/standards. The position is a key point for audits and validation of internal systems and equipment. Oversee the regulatory requirements of various regulatory bodies impacting organ and tissue donation ( FDA, AATB, AOPO, CMS, OPTN ). Acts as point person for a heavy internal and external audit schedule . Use preventative action, nonconformance reporting, and compliant management reporting systems to guide organizational change. Support OSHA regulatory compliance in a clinical setting, including Safety Data Sheet, biohazard disposal, policies and safety records. Here at Donor Alliance, we’re committed to cultivating a workforce as dynamic and diverse as the community we serve. We understand that talent comes in many forms, and we look to hire individuals who bring a willingness to learn and a commitment to excellence. If this describes you, we encourage you to apply regardless of your qualifications. Qualifications & Skills Minimum 3 years' experience in a healthcare setting or regulatory environment required. Previous experience in quality management and/or audit management experience with a variety of regulatory agencies (CMS, FDA, etc,) strongly preferred. Strong interpersonal skills , as this position collaborates with all areas of the organization and external agencies. Strict confidentiality and ethical standards required. Donor Alliance has designed a robust benefits package. To learn more about these offerings, please visit $81,141-$91,284 annually, experience and education considered in offer Exempt (not eligible for overtime) #J-18808-Ljbffr