Regulatory Affairs Specialist II

Job overview

The Regulatory Affairs Specialist II is an onsite role based in Seattle, WA, with compensation ranging from $80,715 to $121,073 per year. This position supports Seattle Children's Research Institute by serving as a subject-matter expert in quality assurance and regulatory compliance. This role guides clinical research teams in adhering to federal regulations, state codes, and institutional policies. The specialist reviews protocols, manages IRB submissions, and develops training programs to ensure a culture of regulatory preparedness and data integrity in clinical research.

What you'll do

• Guides research teams in adhering to federal regulations and IRB requirements.
• Reviews and processes clinical research protocols.
• Assesses and implements regulatory policies.
• Creates and follows standard operating procedures (SOPs).
• Develops and delivers regulatory training.
• Performs quality management activities.
• Ensures data integrity and participant safety.

What we're looking for

Skills & competencies

full-time

day shift

seattle wa

seattle children's

regulatory affairs

research

compliance

onsite

no travel

no on-call

weekend required

$81k-$121k

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, 403(b), life insurance, paid time off, tuition reimbursement.

Why this role

Focus on regulatory preparedness in a pediatric research environment.

About the employer

Seattle Children's is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.