Title: Regulatory Specialist (Medical Device/Biologics) (On-Site)

Location: Woodinville, WA 98072 (Maltby area) - Local candidates only

Payrate: $40/hour + weekly pay + medical benefits

Duration: 3-month contract with great potential for extension

Hours: Full-time | Monday–Friday, 8am–4pm or 9am–5pm (flexible)

Start Date: ASAP

Summary:

Are you the meticulous compliance expert who ensures life-saving medical devices and biologics reach patients safely around the world? Join a global team of innovators as their Regulatory Specialist, where you'll be the guardian of quality and compliance for state-of-the-art instruments and reagents used in life science research laboratories and healthcare facilities worldwide. This on-site role in Woodinville's Maltby area offers excellent compensation with weekly pay and comprehensive medical benefits.

You'll be the trusted regulatory advocate coordinating domestic and international registrations that enable cutting-edge medical products to help people live longer, healthier lives globally. If you're passionate about regulatory excellence and want to make a direct impact on healthcare innovation while working with a supportive Seattle Operations team, this opportunity combines technical expertise with meaningful global impact.

What You'll Do:

• Coordinate critical domestic and international regulatory registrations ensuring life-saving products reach global markets
• Lead regulatory change assessments including weekly coordination meetings, streamlined workflows, and comprehensive documentation
• Serve as the quality champion fostering a compliance-focused environment and mindset throughout the organization
• Manage essential documentation including quality certificates, MOUs, Design History Files, and regulatory records
• Maintain consistency of high-quality standards by aligning local and regional procedures with global processes
• Drive transformative change in how regulatory challenges are tackled across the organization
• Support comprehensive quality and compliance activities including audits, inspections, and regulatory submissions
• Collaborate closely with Seattle Operations Regulatory Affairs team and cross-functional partners
• Escalate regulatory issues appropriately while optimizing processes and procedures for maximum efficiency
• Ensure all product and facility registration activities are completed with precision and timeliness
• Document change assessments thoroughly to maintain regulatory compliance and traceability

What You Bring:

• Bachelor's degree in Biology, Chemistry, Engineering, or related scientific field
• 2+ years of hands-on experience in Regulatory Affairs with proven track record
• Solid experience with IVD/Medical Devices or Biologics in regulated environments
• Knowledge and experience coordinating international regulatory registrations across multiple markets
• Strong proficiency in interpreting and applying US and international regulatory requirements for medical devices
• Excellent organizational skills with attention to detail and ability to manage multiple priorities
• Strong communication and collaboration skills for cross-functional team environments
• Self-motivated approach with ability to work independently while supporting team objectives

Bonus Points If You Have:

• Technical writing skills with experience in regulatory documentation
• Experience with medical device labeling processes and requirements
• Knowledge of FDA regulations and international standards (ISO 13485, MDR, etc.)
• Experience with regulatory submissions and agency interactions
• Background in quality management systems and audit processes
• Experience with change control processes in regulated industries
• Knowledge of clinical trial regulations and compliance requirements

This critical role puts you at the forefront of medical device innovation, where your regulatory expertise directly enables life-saving products to reach patients worldwide. Work on-site in Woodinville with excellent compensation, weekly pay, and comprehensive benefits while building your career with a global healthcare leader. Ready to combine your regulatory expertise with meaningful impact in medical technology? Apply now and help bring breakthrough healthcare solutions to the world.

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.