Federal Regulatory Affairs Coordinator

Description Federal Regulatory Affairs Coordinator - Swedish First Hill (Full Time, Day Shift) Seattle, WA Swedish is seeking a full-time Federal Regulatory Affairs Coordinator - Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research. This includes preparation of all submissions to the IRB to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution. Leads the work of Research Assistants on a task-basis if applicable. Provides on-the-job training, sets priorities and schedules workflow required to support project objectives. Applicants must have: Bachelor's degree in Healthcare Administration, Pharmacy Administration, Regulatory Affairs, or similar healthcare field 2 years of experience as a Regulatory Affairs Specialist, Clinical Data Analyst, or similar regulatory compliance role 1 year experience preparing applications for initial submissions, on-going annual review submissions, and protocol modifications to Institutional Review Board (IRB) About the Team: Providence Swedish is the largest not-for-profit health care system in the greater Puget Sound area. It is comprised of eight hospital campuses (Ballard, Edmonds, Everett, Centralia, Cherry Hill (Seattle), First Hill (Seattle), Issaquah and Olympia); emergency rooms and specialty centers in Redmond (East King County) and the Mill Creek area in Everett; and Providence Swedish Medical Group, a network of 190+ primary care and specialty care locations throughout the Puget Sound. Whether through physician clinics, education, research and innovation or other outreach, we're dedicated to improving the wellbeing of rural and urban communities by expanding access to quality health care for all. Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits Pay Range: $38.67/hour - $61.22/hour The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Check out our benefits page for more information. Apply Today! Applicants that meet qualifications will receive a text with some additional questions from our HireVue system. About Providence At Providence, our strength lies in Our Promise of "Know me, care for me, ease my way." Working at our family of organizations means that regardless of your role, we'll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable. The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities. Providence off