Tucker Parker Smith Group (TPS Group) · 6 hours ago
Regulatory Affairs Specialist
Irvine, CA
Contract
Hybrid
Mid Level
$45/hr - $50/hr
3+ years expTucker Parker Smith Group (TPS Group) is seeking a Regulatory Affairs Specialist II to support a leading manufacturer in the life science research and clinical diagnostics markets. The role focuses on compliance with the EU's In Vitro Diagnostic Regulation (IVDR) and involves revising technical files, supporting labeling conversion projects, and coordinating with cross-functional teams.
Staffing & Recruiting
Hiring Manager
Alexia Armendariz
Responsibilities
Revise assigned technical files using the latest templates to ensure clarity and compliance with IVDR requirements, including incorporation of technical reports, validations, and test data
Meet pre-defined timelines and actively participate in multiple weekly meetings to address issues, answer questions, and provide progress updates to the project manager
Support the IVDR labeling conversion project by updating specifications, tracking logs, and collaborating cross-functionally to ensure compliance
Monitor monthly manufacturing schedules, product fill dates, lot numbers, and change requests for accurate labeling updates
Manage un-CE Marking of selected products and track changes until final labeling reflects updated specifications
Maintain technical file tracking logs and notify regional RA teams of labeling changes
Coordinate with the RA SAP restriction coordinator to restrict specific product lots when required
Qualification
Required
Bachelor's degree in Biochemistry, Biology, Medical Technology, or a related field
3–5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
Strong ability to work both independently and in a collaborative environment
Excellent communication skills, with the ability to negotiate and persuade effectively
Proven analytical, problem-solving, critical thinking, and computer skills
In-depth understanding of Regulatory Affairs policies, practices, and procedures
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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