TCWGlobal
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
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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
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