Fort Worth, TX
Regulatory Affairs Specialist II
Regulatory Affairs Specialist II
Location: Fort Worth, Texas 76104
Schedule: M-F 8:00 AM – 5:00 PM (Hybrid: 3 days on site)
Duration: 12 month assignment (Great potential to extend or convert)
Pay Rate: $45/hr.
On behalf of our client a pharmaceutical company known for the development and manufacturing of a wide range of products for the life science research and clinical diagnostic markets. We are seeking for a Regulatory Affairs Specialist II to support in transition from IVDD to IVDR CE Marking. You will collaborate cross-functionally, update labeling logs, and ensure regulatory compliance.
Responsibilities:
- Provide regulatory support for company's products transitioning from IVDD to IVDR CE Marking.
- Collaborate with cross-functional teams (Quality Assurance, R&D, Marketing) to collect and coordinate regulatory documentation for IVDR compliant technical files.
- Update IVDR Labeling Conversion Log and ensure timely processing of documentation to meet manufacturing schedules.
- Assist in generating Change Requests for product labeling according to the Labeling conversion plan.
- Communicate and assist in the notification process to International Regional Regulatory Affairs departments.
- Ensure implementation of product restrictions as required.
- Perform other IVDR or regulatory-related duties as assigned.
Requirements:
- Bachelor's degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
- 2 to 5 years' experience in Regulatory Affairs and/or QA, R&D, or Manufacturing within the IVD industry.
- Proficiency in computer applications, including ERP systems and basic statistical analysis.