Medical Device Regulatory Specialist
8 hours ago
The Tucker Parker Smith Group (TPS Group) is seeking a seasoned Medical Device Regulatory Specialist to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities.
This role will involve revising technical files, attending meetings with project managers, and updating labeling conversion tracking logs.
Job Responsibilities- Revised Technical Files: Generate technical files using the latest templates, ensuring clear presentation of product characteristics and expected performance.
- Meeting Attendance: Participate in weekly meetings to address issues or questions regarding technical files and update project managers on progress.
- Labeling Conversion: Support cross-functional participation and attend weekly group meetings to follow the conversion plan.
- Log Updates: Update labeling conversion tracking logs based on monthly manufacturing schedules, product fill dates, lot numbers, and change requests.
- Product Un-CE Marking: Support tasks to un-CE mark selected products, track work until final labeling reflects desired changes.
- Miscellaneous Activities: Update technical file tracking logs, notify RA Regional notifications of labeling changes, and restrict product lots as needed.
- Bachelor's degree in biochemistry, biology, medical technology, or related fields.
- 3+ years of experience in RA, QA, R&D, Manufacturing, or Project Management in the IVD industry.
- Knowledge of FDA and CE marking requirements for IVD products.
- Thorough knowledge of policies, practices, and procedures related to RA.
A competitive salary of $45-$49/hour, commensurate with experience, will be offered to the successful candidate. This rate reflects the company's commitment to providing fair compensation for skilled professionals.
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