IVDR Regulatory Affairs Specialist II – Hybrid (TX)

TCWGlobal; Fort Worth (TX); On-site; USD 61,992 - 68,880; Full time

Benefits offered by this job

Weekly pay

Medical benefits

Job summary

A leading global provider in life sciences is looking for a Regulatory Affairs Specialist to support IVDR transition efforts, focusing on technical file remediation, labeling conversions, and regulatory compliance. The ideal candidate will possess 3-5 years of experience in Regulatory Affairs within the IVD industry, strong attention to detail, and the ability to handle multiple regulatory deliverables within tight timelines. This is a full-time onsite position based in Fort Worth, TX, requiring local applicants only.

Qualifications

• 3-5 years of experience in Regulatory Affairs or related functions within the IVD industry.
• Hands-on experience maintaining IVD technical files.
• Familiarity with EU IVDR and CE marking requirements.

Responsibilities

• Support IVDR technical file remediation activities.
• Participate in the IVDR labeling conversion project.
• Maintain and update technical file tracking logs.

Skills

Regulatory Affairs experience

Attention to detail

Problem-solving

Communication skills

Team collaboration

Education

Bachelor's degree in Biochemistry, Biology, Medical Technology or related

Job description

A leading global provider in life sciences is looking for a Regulatory Affairs Specialist to support IVDR transition efforts, focusing on technical file remediation, labeling conversions, and regulatory compliance. The ideal candidate will possess 3-5 years of experience in Regulatory Affairs within the IVD industry, strong attention to detail, and the ability to handle multiple regulatory deliverables within tight timelines. This is a full-time onsite position based in Fort Worth, TX, requiring local applicants only.