Regulatory Affairs Specialist ( IVDR)

TCWGlobal; Fort Worth (TX); On-site; USD 61,992 - 68,880; Full time

Benefits offered by this job

Weekly pay

Medical benefits

Job summary

A leading global provider in life sciences is looking for a Regulatory Affairs Specialist to support IVDR transition efforts, focusing on technical file remediation, labeling conversions, and regulatory compliance. The ideal candidate will possess 3-5 years of experience in Regulatory Affairs within the IVD industry, strong attention to detail, and the ability to handle multiple regulatory deliverables within tight timelines. This is a full-time onsite position based in Fort Worth, TX, requiring local applicants only.

Qualifications

• 3-5 years of experience in Regulatory Affairs or related functions within the IVD industry.
• Hands-on experience maintaining IVD technical files.
• Familiarity with EU IVDR and CE marking requirements.

Responsibilities

• Support IVDR technical file remediation activities.
• Participate in the IVDR labeling conversion project.
• Maintain and update technical file tracking logs.

Skills

Regulatory Affairs experience

Attention to detail

Problem-solving

Communication skills

Team collaboration

Education

Bachelor's degree in Biochemistry, Biology, Medical Technology or related

Job description

Regulatory Affairs Specialist (IVDR)

Base pay range

$45.00/hr - $50.00/hr

Location: Fort Worth, TX (Onsite - local candidates only)

Work Arrangement: Hybrid

Third onsite day: Flexible (candidate’s choice)

Contract Length: 1 year

Pay Rate: $45–$50/hour (Weekly pay & Medical benefits)

MUST BE LOCAL - NOT ACCEPTING APPLICANTS OUTSIDE OF TEXAS

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state‑of‑the‑art instruments and reagents for life‑science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives.

Role Overview

We are seeking a Regulatory Affairs Specialist II to support the European Union In Vitro Diagnostic Regulation (IVDR) transition efforts impacting Bio‑Rad products currently CE‑marked under the IVD Directive. This role will focus on technical file remediation, labeling conversions, regulatory tracking, and cross‑functional collaboration to ensure compliance with IVDR requirements.

The ideal candidate has hands‑on regulatory experience in the IVD industry, strong attention to detail, and the ability to manage multiple regulatory deliverables within defined timelines.

How the Candidate Will Make an Impact

• Support IVDR technical file remediation activities by revising assigned technical files using the latest approved templates. Ensure each file clearly documents product characteristics, intended use, performance, and evidence of conformity, including all required technical reports, validations, test reports, and supporting documentation. Meet predefined timelines and participate in multiple weekly project meetings to address issues, elevate risks, and provide progress updates to the project manager.
• Support the IVDR labeling conversion project through cross‑functional collaboration. Participate in weekly working sessions, update labeling conversion tracking logs based on manufacturing schedules, product fill dates, lot numbers, and change request numbers, and revise labeling specifications as needed to align with IVDR requirements.
• Support activities to un‑CE‑mark selected products by executing required regulatory and labeling updates and tracking progress until final labeling reflects approved changes per labeling specification documents.
• Maintain and update technical file tracking logs, coordinate and track RA regional notifications related to labeling changes, and notify the RA SAP restriction coordinator when specific product lots require distribution restrictions for certain global regions.
• Support additional regulatory and compliance‑related activities as needed to ensure timely and accurate execution of IVDR transition initiatives.

What the Candidate Brings (Requirements)

• Bachelor’s degree in Biochemistry, Biology, Medical Technology, or a related scientific discipline
• 3–5 years of experience in Regulatory Affairs and/or related functions such as Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
• Hands‑on experience preparing, revising, or maintaining IVD technical files, including technical reports, validations, and test documentation
• Working knowledge of EU IVDR, CE marking requirements, and familiarity with FDA regulations for IVD products (preferred)
• Experience supporting labeling changes, labeling specifications, and regulatory tracking logs
• Ability to manage multiple regulatory deliverables simultaneously while meeting defined deadlines
• Strong written and verbal communication skills, including the ability to collaborate cross‑functionally and participate in recurring project meetings
• Proven ability to work independently as well as within team‑based environments
• Strong analytical, problem‑solving, critical thinking, and computer skills
• Solid understanding of Regulatory Affairs policies, practices, and procedures

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Quality Assurance