Regulatory Affairs Coordinator

Location 200 Spruce Street,Denver, CO, 80230,United States Description 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 cultivate 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. $81,141-$91,284 annually, experience and education considered in offer. Exempt (not eligible for overtime). Health insurance. Vision insurance. Student Loan Repayment. Paid Time Off. Variety of voluntary benefits. Applications will be accepted for three weeks from the posting date noted at the bottom of this posting. To ensure optimal consideration during the interview process, applicants are strongly encouraged to submit their interest as early as possible. Donor Alliance is the federally-designated, Association of Organ Procurement Organizations (AOPO) and American Association of Tissue Banks (AATB) accredited, non-profit organ procurement organization serving Colorado and most of Wyoming. As a recognized leader in facilitating the donation and recovery of transplantable organs and tissues, Donor Alliance’s mission is to save lives through organ and tissue donation and transplantation. To achieve this mission, Donor Alliance employs effective family approach and recovery programs in more than 100 hospitals. Donor Alliance also inspires the public to register as organ and tissue donors through community partnerships, public outreach and education campaigns throughout its donation service area. #J-18808-Ljbffr