Regulatory Affairs Specialist II

About the role

Serves as a subject-matter expert in quality assurance and regulatory support for clinical research at Seattle Children’s Research Institute. Guides and supports all clinical research team members in adhering to applicable federal regulations, state codes, institutional policies, and Institutional Review Board (IRB) oversight and review requirements when conducting research with human participants.

Reviews, analyzes, and processes clinical research protocols, including associated documents, for submission to local and commercial IRBs. Assesses, analyzes, and implements regulatory requirements, policies, and guidance documents; creates and follows standard operating procedures (SOPs). Develops and delivers training and education to build and reinforce a culture of regulatory preparedness and quality assurance in clinical research practices, structures, and systems.

Implements proven practices to ensure the quality of data collection and integrity, and documentation. Performs quality management activities in clinical research, ensuring research participants’ safety, quality of study operations, and compliance with applicable research regulations and ICH/GCP guidelines.

Requirements

• Bachelor’s Degree in biological sciences or health-related field.
• Minimum of two (2) years experience in the pharmaceutical industry or clinical research organization in for-profit or academic setting.

Qualifications

Preferred:

• Master’s Degree in biological sciences or health-related field.
• At least five (5) years experience in a regulatory role.
• Experience in drug and device approval process.
• RAPS certification or equivalent.

Pay

Compensation range: $80,715.00 - $121,073.00 per year (based on full-time employment of 2,080 hours per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided. This range is specific to Seattle; positions located outside of Seattle may be compensated differently.

Benefits

Seattle Children’s offers a generous benefit package, including:

• Medical, dental, and vision plans
• 403(b) retirement plan
• Life insurance
• Paid time off
• Tuition reimbursement

Additional details can be found on our benefits webpage.

About Us

Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible.

Our founding promise to the community is as valid today as it was over a century ago: we will care for all children in our region, regardless of the families’ ability to pay. Together, we deliver superior patient care, advance new discoveries and treatments through pediatric research, and serve as the pediatric and adolescent, academic medical center for Washington, Alaska, Montana, and Idaho – the largest region of any children’s hospital in the country.

U.S. News & World Report consistently ranks Seattle Children’s among the nation’s best children’s hospitals. For more than a decade, we have been nationally recognized in key specialty areas. We are honored to be one of the nation’s very best places to care for children and the top-ranked pediatric hospital in Washington and the Pacific Northwest.

As a Magnet designated institution, we recognize the importance of hiring and developing great talent to provide best-in-class care to the patients and families we serve. Our organizational DNA takes form in our core values: Compassion, Excellence, Integrity, Collaboration, Equity, and Innovation. Whether it’s delivering frontline care to our patients in a kind and caring manner, practicing the highest standards of quality and safety, or being relentlessly curious as we work towards eradicating childhood diseases, these values are the fabric of our culture and community.