New

Regulatory Specialist-Medical Devices (ONSITE)

YOH Services LLC
401(k)
United States, Washington, Woodinville
May 14, 2025
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 working in Woodinville, WA . Pay Rate: $33-40/hr ONSITE What You'll Be Doing: Coordinating the Domestic and Intl Registration Requests and apply your 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 cross functional teams to ensure all the product and facility registration activities are complete and change assessments are documented as needed. 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 Bio-Rad 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 Required: 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. What's In It For You? This is a unique opportunity to support our client; one of the world's largest biotechnology companies. Medical benefits and 401K are available. Get Hired, Apply Now! Yoh makes finding and applying for jobs simple. Partner with Yoh Staffing to find the right opportunities across multiple industries in the US and UK. Find out more here! Recruiter: Lisa Hughes Estimated Min Rate: $33.00 Estimated Max Rate: $40.00 Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.