Regulatory Affairs Specialist

Radiant Systems Inc; Woodinville (WA); On-site; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Regulatory Affairs Specialist to ensure compliance with local and international regulations. The role involves coordinating regulatory registrations, maintaining quality standards, and driving process improvements. Ideal candidates will have a Bachelor's degree in a related field and experience in regulatory affairs, particularly with IVD and medical devices.

Qualifications

• Minimum of 2 years’ experience in Regulatory Affairs.
• Experience with IVD/Medical Devices/Biologics.

Responsibilities

• Coordinate Domestic and International Regulatory Registrations.
• Maintain consistency of high-quality standards across the Company.
• Drive change and support quality and compliance activities.

Skills

Leadership

Technical Writing

Regulatory Compliance

Education

Bachelor's degree in Biology, Chemistry, Engineering

Job description

This range is provided by Radiant Systems Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$35.00/hr - $40.00/hr

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Research and Engineering

• Industries

  Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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