IVDR Regulatory Affairs Specialist II – IVD

Tucker Parker Smith Group (TPS Group); Dallas (TX); On-site; USD 61,992 - 66,124; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading global life sciences firm is seeking a Regulatory Affairs Specialist II to support the transition to EU In-Vitro Diagnostic Regulation (IVDR). The role focuses on revising documentation and ensuring compliance with regulatory standards. The ideal candidate will have a relevant Bachelor's degree and 3–5 years of experience in Regulatory Affairs or Quality Assurance within the IVD sector. Benefits include medical and vision insurance, as well as a 401(k).

Qualifications

• 3–5 years of experience in Regulatory Affairs, Quality Assurance, or related fields within IVD or medical device industry.
• Knowledge of FDA and CE marking requirements for IVD products preferred.
• Demonstrated ability to work independently and as part of a team.

Responsibilities

• Support the IVDR transition project by reviewing and revising technical files.
• Ensure technical files present product characteristics, performance, and evidence of conformity.
• Collaborate on labeling conversion projects and maintain change tracking logs.

Skills

Strong analytical and problem-solving skills

Excellent communication and interpersonal skills

Proficient in technical writing

Organizational skills

Education

Bachelor’s degree in Biochemistry, Biology, Medical Technology, or related scientific field

Job description

A leading global life sciences firm is seeking a Regulatory Affairs Specialist II to support the transition to EU In-Vitro Diagnostic Regulation (IVDR). The role focuses on revising documentation and ensuring compliance with regulatory standards. The ideal candidate will have a relevant Bachelor's degree and 3–5 years of experience in Regulatory Affairs or Quality Assurance within the IVD sector. Benefits include medical and vision insurance, as well as a 401(k).