Clinical Data Analyst

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

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 1996. Our mission is to deliver top-quality talent, the first time and every time. We provide resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description

Duration: 12 Months + Contract

Summary of Position:

Required Competencies:

• Experience in technical and clinical data review.
• Attention to detail and problem-solving skills.
• Excellent verbal, written, and presentation skills.
• Ability to work independently.

Desired Competencies:

• Working knowledge of EU IVD regulations.
• Working knowledge of IVD products and regulations.
• Familiarity with web-based content sharing applications (e.g., SharePoint), Microsoft Office Suite, Adobe.

Responsibilities

Assess client’s products based on classification, identify gaps against the Technical Documentation (Annex II - 2017/746), and determine resources needed for addressing gaps for budget planning. Create draft Performance Evaluation reports for a sample of Class B, C, and D products. Suggest opportunities to fill gaps with data from sources like published literature or post-market data. Provide periodic updates to the IVDr Project Lead as scheduled.

Comments/Special Instructions

Knowledge of EU IVD Regulations is a plus.

Qualifications

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

Additional Information

Feel free to share this opportunity with colleagues. Referral bonuses are provided.

Thanks,

Warm Regards,

Nisha

Integrated Resources, Inc.

Specializing in IT, Rehab, Clinical, Nursing