Federal Regulatory Affairs Coordinator

Description

Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.

Federal Regulatory Affairs Coordinator - Swedish First Hill (Full Time, Day Shift)

Seattle, WA

Swedish is seeking a full-time Federal Regulatory Affairs Coordinator. This role prepares, facilitates, coordinates, and submits documentation required by federal, state, and local regulations and institutional requirements relating to the conduct of research.

Responsibilities include 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.

The coordinator leads the work of Research Assistants on a task-basis if applicable, providing on-the-job training, setting priorities, and scheduling workflow required to support project objectives.

Minimum Qualifications :

• 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, ongoing 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 and a network of 190+ primary care and specialty care locations throughout the Puget Sound.

We’re dedicated to improving the wellbeing of rural and urban communities by expanding access to quality health care for all.

Equal Opportunity Employer :

Providence is committed to the principle that every workforce member has the right to work in surroundings that are free from all forms of unlawful discrimination and harassment.

We believe diversity makes us stronger, so we are dedicated to shaping an inclusive workforce.

Benefits :

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, 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, and bonus opportunities.

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. We provide best-in-class benefits and foster an inclusive workplace where diversity is valued.

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