1. Primarily responsible for contributing to the implementation and execution of In Vitro Diagnostic Medical Device Regulation (IVDR) activities through medical assessments of Laboratory Diagnostics (LD) products.
2. Serve as a medical consultant to project teams for preparation of IVDR performance evaluation reports.
3. 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.
4. Contribute to post-market surveillance activities in alignment with LD policies and procedures and applicable standards/regulations.
5. Reports directly to Siemens Medical Affairs
Key Job Attributes
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:
1. 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.
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.
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
I look forward to hearing from you
APN Software Services, Inc .
39899 Balentine Drive, Suite 385, Newark, CA 94560 .
Ph.: 510-623-5050 Ext. 107 | Fax: 510.623.5055 | Email: firstname.lastname@example.org