Regulatory Affairs Specialist (R&D/QA)

Job Description

Job Description

Regulatory Affairs Specialist (R&D / QA)

Fort Worth, TX 76104 (*Local candidates- 3 days on site / 2 days remote)

$43-$45hr (Weekly pay + Benefits)

1yr contract (Excellent potential for extension or permanent)

Full-time- M-F 8am-5pm

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world.

Together they are helping people everywhere live longer, healthier lives. They are looking for Regulatory Affairs Specialist to join the team! Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all products currently CE Marked under the IVD Directive.

Activities include preparation of new IVDR Technical File, revision of technical file when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.

How You'll Make An Impact :

• Provide regulatory support for products that will be transitioning from the IVDD to IVDR CE Marking.
• Collaborate with cross-functional groups (e.g., Quality Assurance, Research & Development, Marketing) to collect and coordinate information and regulatory documentation to assemble IVDR compliant technical files.
• Update IVDR Labeling Conversion Log, assure all documentation is prepared and processed timely to meet the manufacturing schedule.
• Assist in the generation of Change Requests for product labeling according to Labeling conversion plan.
• Communicate and assist in the notification process to all International Regional RAs. This may include sending the notification, logging regional responses and tracking RA Regional activities to completion.

Ensure product restrictions are implemented, as required.

Perform other IVDR or regulatory related duties as required or assigned.

What You Bring :

• Bachelors degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
• 2-8 years of experience in Regulatory affairs, and / or experience in Quality Assurance, (R&D), Manufacturing preferably within IVDR (Vitro Diagnostic Regulation)
• Experience with labeling, change request for product labeling and assuring all documentation is timely to meet manufacturing schedule.
• IVDR Vitro Diagnostic Regulation industry is a big plus
• Excellent computer applications skills; experience with ERP systems
• Able to perform basic statistical analysis.
• Effective communication skills, both written and oral
• Strong documentation and organizational skills

Please send your resume. Thank you!

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation.