Regulatory Affairs Specialist – Temp 2025-36990
Irvine, California | Contract | $45.00 - $50.00
June 26, 2025 | Job ID: 2187001
Job Summary
You are a detail-oriented Regulatory Affairs professional with 3–5 years of experience in RA, QA, R&D, Manufacturing, or Project Management within the In Vitro Diagnostics (IVD) industry. You are knowledgeable in FDA and CE marking requirements and skilled in technical documentation, labeling, and cross-functional collaboration.
This position pays: $45 - 50/hr.
What you will be doing:
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Supporting the EU’s In Vitro Diagnostic Regulation (IVDR) transition for all CE-marked Bio-Rad products.
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Revising and updating technical files to meet IVDR requirements using the latest templates and documentation.
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Participating in weekly meetings to resolve issues, provide updates, and meet project deadlines.
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Assisting in the IVDR labeling conversion project by updating specifications, tracking logs, and coordinating with cross-functional teams.
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Managing the un-CE marking process for select products and ensuring final labeling reflects required changes.
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Performing miscellaneous activities including updating tracking logs, notifying regional RA teams of labeling changes, and coordinating product restrictions in SAP.
What you bring:
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A Bachelor's degree in biochemistry, biology, medical technology, or a related field.
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3–5 years of experience in regulatory affairs or a related discipline within the IVD industry.
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Strong understanding of FDA and CE regulatory requirements (IVD experience preferred).
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Excellent analytical, communication, problem-solving, and computer skills.
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Ability to work both independently and collaboratively in a fast-paced environment.
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Solid understanding of RA policies, practices, and procedures.
Leslie Carey
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About Us
If You’re Looking For A New Opportunity, The Recruiting And Staffing Experts At Nelson Connects Can Help. We Work With Companies Of All Types And Sizes Across All Industries. We Help People Like You Find Exciting Roles With Employers Ranging From Fortune 100, Government, And Nonprofit Organizations To Local Businesses, Industry Leaders, And The Most Agile Start-Ups. The Candidates We Work With Appreciate Our Responsive Approach, Genuine Relationships, And Exceptional Service. With A Commitment To Transparency, Authenticity, And Credibility, We Look Forward To Our Jobs Every Day, And We’re Excited To Help You Find The Job You’ve Been Looking For.
Pay Transparency: Nelson Connects Provides Pay Transparency By Placing Salary Ranges In All Job Postings In Accordance With State And Local Regulations. We Are Committed To Communicating Pay Clearly Throughout The Employment Process.
California Fair Chance Act And Beyond: Qualified Applicants With Criminal Histories Will Be Considered For Employment In Accordance With Applicable Regulations. We Will Consider Qualified Applicants For Employment, Including Those With Criminal Histories, In A Manner Consistent With The Requirements Of Applicable State And Local Laws, Including The City Of Los Angeles’ Fair Chance Initiative For Hiring Ordinance, San Francisco Fair Chance Ordinance, And CA Fair Chance Act.
Temporary Associate Benefits Offered: Weekly Benefits Offered Include Medical, Dental, Vision, HSA, EAP, Life/AD&D, STD, Commuter FSA, + State Mandated Benefits.
EEO Statement: Nelson Connects is an equal-opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or any other classification protected by law.
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