Quality Professional 4
Company: rose international
Posted on: July 12, 2019
Position Number: 318526
Location: Newark, DE
Desired Skill Set:
Technical, Regulatory Coordinator, Regulatory Affairs, Quality
Control, Medical device, Marketing, Laboratory, Clinical
- *C2C is not available**
- *Only U.S. Citizens and those authorized to work in the U.S.
can be considered as W2 candidates.**
Job Title: Quality Professional 4
Location: Newark, DE 19702
Duration: 12+ Months
Schedule: Shift 1; M-F (8:00 AM - 5:00 PM)
- Primarily responsible for contributing to the implementation
and execution of In Vitro Diagnostic Medical Device Regulation
(IVDR) activities through medical assessments of Client Laboratory
Diagnostics (LD) products.
- Serve as a medical consultant to project teams for preparation
of IVDR performance evaluation reports.
- Advise on medical risks and benefits to evaluate product safety
and effectiveness in laboratory medicine in support of functional
group activities for commercialized/marketed products as well as
for product development activities.
- Contribute to post-market surveillance activities in alignment
with LD policies and procedures and applicable
- Reports directly to Client LD Medical Affairs
Key Job Attributes:
- Within specific job description:
- Works independently or as part of a larger team in the
execution of assigned projects.
- Maintains accurate documentation and files related to medical
risk-benefit analyses and/or post-market surveillance
- Interacts directly with regulatory, clinical, marketing, and
R&D as needed during the course of risk-benefit analyses and/or
post-market surveillance activities and builds productive
cross-functional working relationships.
- Critically reviews analytical and clinical performance data and
reports and provides assessment of overall scientific and
Critical Problem Thinking:
- Demonstrates understanding of functionality/intended use of
complex in vitro diagnostic laboratory medical devices and the
application of medical laboratory results (e.g. biomarkers) in
- Displays an expert level of critical thinking in applying
principles of clinical laboratory medicine, including analytical
laboratory practice (eg assay validation, quality control),
regulations and clinical applications.
- Proactive attitude with logical, data driven approach to
- Performs special assignments and provides technical and
clinical advice in area of expertise.
- M.D., Ph.D. or M.D./Ph.D. in related areas with practical
experience in clinical pathology preferred.
- Equivalent combination of relevant education and experience,
such as Masters in medical technology, laboratory science,
chemical, physical, or biological science AND a minimum of 3 years
of medical laboratory experience in clinical consultancy and
technical and regulatory oversight, as outlined above, may be
substituted as appropriate.
- Board certification and ongoing accreditation by nationally and
internationally known professional clinical and academic bodies
such as ABCC, NRCC, CACB, RCP, and ABP preferred.
- Typically 3 to 5 years of successful experience in a clinical
laboratory diagnostics position.
- Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly
Keywords: rose international, Newark , Quality Professional 4, Other , Newark, Delaware
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