Regulatory Technical Specialist 4

Title: Regulatory Technical Specialist 4 
 Location: Newark-DE
Duration: 10+ months with possible extension
 
A. Within specific job description: 
1. Works independently or as part of a larger team in the execution of assigned projects. 
2. Maintains accurate documentation and files related to risk-benefit analyses and/or post-market surveillance activities. 
3. 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. 
4. Critically reviews analytical and clinical performance data and reports and provides assessment of overall scientific and clinical validity. 
B. Critical Problem Thinking: 
. Demonstrates understanding of functionality/intended use of complex in vitro diagnostic laboratory medical devices and their application in clinical practice. 
 2. 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. 
 3. Proactive attitude with logical, data driven approach to problem solving. 
 4. Performs special assignments and provides technical and clinical advice in area of expertise. 
Education: 
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, CACB, RCP, ABP preferred. 
D. Experience: 
1. Typically 3 to 5 years of successful experience in related field. 
 2. Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly desirable.
  
Please send me your confirmation that no one else has contacted you for this position apart from APN Team.
Please send me your updated copy of resume along with the best number to reach you ASAP.
 
Many Thanks
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560 
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com

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