Senior Regulatory Affairs Specialist — Document Control and Records Management

Job overview

The Senior Regulatory Affairs Specialist role is onsite in Chaska, MN, with compensation of $50–$53.95 per hour. The position supports Beckman Coulter regulatory programs, including post-market regulatory affairs activities. The specialist coordinates regulatory compliance and submissions for medical devices, helping the organization meet applicable requirements through complaint-program administration, reporting, documentation, and review of product materials and labeling. The role may also assist technical departments, manufacturing business centers, and suppliers with clinical data for pre-market notifications.

What you'll do

• Plan, coordinate, facilitate, and report on regulatory programs
• administer complaint management for corporate compliance
• plan and implement pre-market registration, reporting, and compliance activities
• implement global corrective-action and adverse-event reporting programs
• prepare regulatory submissions
• and review promotional materials, experimental designs, data analysis, and product labeling as they relate to registration and commercialization.

What we're looking for

Skills & competencies

senior regulatory affairs specialist

document control

records management

medical devices

onsite

chaska mn

lancesoft

regulatory submissions

post-market compliance

$50-$53.95/hr

Work arrangement

• Weekend coverage required

Why this role

Bachelor’s degree with five years of experience or master’s degree with three years of experience; medical technologist background and in-vitro diagnostics experience are strongly desired.

About the employer

LanceSoft Inc is hiring for this role. Industry: Employment Placement Agencies. Sector: 56.