Full-Time
Clinical Data Analyst
Integrated Resources
501-1,000 employees
No salary listed
Rochester, NY, USA
In Person
 Data & Analytics (1) |
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- Experience in a role in regulated healthcare industry and preferably in a Medical Device/IVD regulated industry.
- 5+ years’ experience in a role in regulated healthcare industry and preferably in a Medical Device/IVD regulated industry.
- Based on the classification assessment of the client’s products undertake an assessment of a sample of different classes of product against the Technical Documentation (Annex II - 2017/746) and identify any gaps and in particular significant gaps.
- From the representative product sample identify the time and resources required to address any gaps that can be used for budget planning purposes in 2018/19, particularly if product testing or performance evaluations are required.
- Create draft Performance Evaluation reports for a representative sample of Class B, C and D products.
- Propose opportunities for filling any identified gaps with data from other sources such as published literature, post-market data.
- Provide periodic updates to the IVDr Project Lead at a frequency to be determined.
- Working knowledge of EU IVD regulations.
- Working knowledge of IVD products and regulations.
- Familiarity with web-based content sharing applications (i.e. SharePoint), Microsoft Office Suite, Adobe.
- Candidates with knowledge of EU IVD Regulations is a plus.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.