What are the responsibilities and job description for the Regulatory Affairs Specialist position at Tucker Parker Smith Group (TPS Group)?
Regulatory Affairs Specialist II
Irvine, CA (Hybrid: Core days Tue/Thurs 1 flexible onsite day)
12-Month Assignment (potential to extend / convert)
Pay: $45–$50/hr
On behalf of our client, a leading manufacturer and seller of products for the life science research and clinical diagnostics markets, we are seeking a Regulatory Affairs Specialist II to join their team. This role will focus on supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities impacting all products currently CE Marked under the IVD Directive.
Key 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.
Qualifications
- 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.
- Knowledge of FDA and CE marking requirements for IVD products strongly preferred.
- 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.
Please submit your resume in Word or PDF format to be considered.
Salary : $45 - $50