Regulatory Specialist-Medical Devices (ONSITE)

YOH Services LLC; Woodinville (WA); On-site; Full time

Job summary

A leading biotechnology company is seeking a Regulatory Specialist for a contract role in Woodinville, WA. The ideal candidate will coordinate regulatory submissions and ensure compliance with international standards. This position offers competitive pay and benefits including medical and 401K. Join a dynamic team and contribute to innovative medical device solutions.

Benefits

Medical

401K

Qualifications

• At least 2 years of experience in Regulatory Affairs related to IVD/Medical Devices/Biologics.
• Experience with international registration coordination.

Responsibilities

• Coordinate domestic and international registration requests.
• Manage documentation including quality certificates and Design History Files.
• Support quality and compliance activities, including audits and inspections.

Skills

Regulatory Affairs

Technical Writing

Compliance

Education

Bachelor's degree in Biology, Chemistry, Engineering

Job description

Regulatory Specialist-Medical Devices (ONSITE)

Category:
Regulatory

Employment Type:
Contract

Reference:
BH-385322

Regulatory Specialist-Medical Devices (ONSITE)

Needed for a temporary contract opportunity with Yoh Staffing's client in Woodinville, WA.

• Pay Rate: $33-40/hr
• Location: Onsite in Woodinville, WA

What You'll Be Doing:

• Coordinate domestic and international registration requests, ensuring compliance with local and international regulations, and work with cross-functional teams to complete registration activities and change assessments.
• Manage documentation including quality certificates, MOUs, Design History Files, and other records.
• Maintain high-quality standards by aligning local and regional procedures with global processes.
• Support quality and compliance activities, including audits and inspections, and foster a quality environment.

Required Qualifications:

• Bachelor's degree in Biology, Chemistry, Engineering, or related field.
• At least 2 years of experience in Regulatory Affairs related to IVD/Medical Devices/Biologics, with international registration coordination.
• Experience with technical writing and labeling processes is preferred.
• Knowledge of US and international regulatory requirements for IVD/Medical Devices/Biologics.

What’s In It For You?

• Support a leading biotechnology company with benefits including medical and 401K.

Apply now to join Yoh Staffing, a trusted partner across industries in the US and UK. For more info, visit our website.

Recruiter: Lisa Hughes

Estimated Rate Range: $33.00 - $40.00/hr

Note: Pay ranges are estimates; actual pay depends on experience and qualifications. All qualified applicants are encouraged to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. For accommodation requests, visit our website.

Applicants in California are considered under applicable local laws regarding criminal records.

Your privacy is important. Please apply directly through the employer’s website.