Clinical Data Analyst - IVD Regulatory Review (Contract)

Integrated Resources Inc.; City of Rochester (NY); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Referral bonuses

Job summary

A prominent staffing firm is seeking a qualified professional to evaluate medical devices and IVD products for compliance with EU regulations. The role involves assessing gaps in technical documentation and generating performance evaluation reports. Ideal candidates will have significant experience in the healthcare industry, particularly in Medical Device or IVD, and strong problem-solving skills.

Qualifications

• 5+ years of experience in regulated healthcare, preferably Medical Device/IVD.
• Experience in R&D or Clinical Affairs preferred.
• Knowledge of EU IVD regulations is a plus.

Responsibilities

• Assess client’s products based on classification and identify gaps.
• Create draft Performance Evaluation reports for Class B, C, and D products.
• Provide periodic updates to the IVDr Project Lead.

Skills

Attention to detail

Problem-solving

Verbal communication

Written communication

Presentation skills

Tools

Microsoft Office Suite

Adobe

Job description

A prominent staffing firm is seeking a qualified professional to evaluate medical devices and IVD products for compliance with EU regulations. The role involves assessing gaps in technical documentation and generating performance evaluation reports. Ideal candidates will have significant experience in the healthcare industry, particularly in Medical Device or IVD, and strong problem-solving skills.