Senior Regulatory Affairs Specialist

Hiring By - Biostaffic

 BioPharma

Fort Worth, Texas - United States

Job Highlights

Not Disclosed

Associate

Posted 4 months ago
Job details

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.


Please submit resume in PDF or Word Format to be considered.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Fort Worth, Texas - United States

Experience:

  • Associate

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 13, 2024
Company Overview
Tucker Parker Smith Group (TPS Group)
Tucker Parker Smith Group (TPS Group)

Current Openings: 0

The Tucker Parker Smith Group ( TPS Group), is a professional recruiting and staffing firm. We provide amazing job opportunities for people to work, on a contract basis or thru Direct Hire placement, at top companies. Our valued client network ranges from Fortune 500 companies to regional and local businesses in multiple industries. The reasons for our success are as simple and straightforward as the philosophy that motivated the formation of our firm: we have a passion for what we do and value the responsibility that candidates and our clients entrust us with daily.
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