Regulatory Specialist ( Medical Device/Biologics)

Woodinville, WA 98072 (Maltby area) **Onsite- local candidates only

$40hr ( Weekly pay + medical benefits)

3 month contract ( Great potential for extension)

Full-time M-F 8am-4pm or 9am-5pm

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives!

Support company’s commitment to quality and compliance by coordinating the Domestic and Intl Registration Requests as a Regulatory Specialist. As part of Seattle Operations RA team, you’ll apply your strong leadership skills and knowledge of regulatory requirements to ensure that we register and distribute products that are in compliance to local and international regulations and applicable standards, escalate issues as necessary, complete necessary documentation and optimize our processes and procedures. You’ll also work closely with SO RA team and cross functional teams to ensure all the product and facility registration activities are complete and change assessments are documented as needed.

How You'll Make An Impact:

• Help to create and foster a quality environment and mindset throughout the business by coordinating the Domestic and International Regulatory Registrations, Regulatory Change Assessment including weekly meetings, workflows and documentation, and escalations
• Document management: Maintains and stores records in the file room including but not limited to current quality certificates, MOUs, Design History Files, and other records as assigned.
• Maintain the consistency of high-quality standards across by aligning local and regional procedures with our global processes and expectations
• Drive change and transform the way we tackle challenge with support for additional quality and compliance activities, including audits and inspections

What You Bring:

• Bachelor's degree, or equivalent, in Biology, Chemistry, Engineering, or related field.
• 2+ years’ experience in Regulatory Affairs
• Experience relating to IVD/Medical Devices or Biologics
• Some knowledge with the responsibility in coordination of international regulatory registrations.
• Bonus: Technical Writing Skills and experience with labeling process
• Proficiency in interpretation and application of US and outside US regulatory requirements for IVD/Medical Devices/Biologics or similar .

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