Tucker Parker Smith Group (TPS Group) · 1 day ago
Regulatory Affairs Specialist
DFW Metroplex
Contract
Hybrid
Mid Level
$45/hr - $48/hr
3+ years expTucker Parker Smith Group (TPS Group) is a global leader in life science research and clinical diagnostics, dedicated to advancing scientific discovery and improving healthcare outcomes worldwide. The Regulatory Affairs Specialist II will support the transition to the EU In Vitro Diagnostic Regulation by revising technical documentation, updating product labeling, and ensuring compliance with IVDR requirements.
Staffing & Recruiting
Hiring Manager
Alexia Armendariz
Responsibilities
Support the IVDR transition project by reviewing and revising assigned technical files using the latest templates and regulatory standards
Ensure each technical file clearly presents the product’s characteristics, performance, and evidence of conformity, incorporating current technical reports, validations, and test data
Complete assigned technical files within established timelines and participate in weekly team meetings to discuss progress, address issues, and provide updates to the project manager
Collaborate on the IVDR labeling conversion project, updating labeling specifications and tracking logs to align with monthly manufacturing schedules, product fill dates, and change requests
Maintain oversight of labeling conversion progress, ensuring updates are accurately reflected in product documentation and technical files
Support activities related to the un-CE marking of selected products and track progress until final labeling reflects the required updates
Maintain technical file and labeling change tracking logs, notify regional regulatory affairs teams of changes, and coordinate with the RA SAP restriction coordinator when specific product lots need distribution restrictions
Perform other related regulatory and documentation support tasks as needed to ensure compliance and project success
Qualification
Required
Bachelor's degree in Biochemistry, Biology, Medical Technology, or a related scientific field
3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD or medical device industry
Strong analytical and problem-solving skills, with a detail-oriented and organized approach
Excellent communication and interpersonal skills, including the ability to collaborate effectively across departments
Proficient in technical writing, data management, and computer applications relevant to regulatory documentation
Demonstrated ability to work independently and as part of a cross-functional team
Preferred
Knowledge of FDA and CE marking requirements for IVD products strongly preferred
Company
Tucker Parker Smith Group (TPS Group)
The Tucker Parker Smith Group ( TPS Group), is a professional recruiting and staffing firm.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brian Smith
Co-Founder & Managing Partner
N
Nichole Tonning-Smith
Co-Founder & Chief Operations Officer
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