Job Description

Duration: 3 months contract

Onsite 8:00 AM-4:00 PM or 9:00-5:00 PM. 40 hrs a week

Description :

• Support Client's commitment to quality and compliance by coordinating the Domestic and Intl Registration Requests as a Regulatory Specialist.
• As part of Client’s 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 the Company 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.
• Minimum of 2 years’ experience in Regulatory Affairs, or equivalent combination of education and experience relating to IVD/Medical Devices/Biologics, with responsibility in coordination of international regulatory registrations.
• Technical Writing Skills and experience with labeling process is preferred.
• Proficiency in interpretation and application of US and outside US regulatory requirements for IVD/Medical Devices/Biologics.

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