Quality Professional

Job Title

Business Unit / Segments Laboratory Diagnostics (LD) (Products: Chemistry, Immunochemistry, Automation, Informatics, Hematology, Hemostasis, and Specialty Products)

Specific Responsibilities

Responsible for contributing to the implementation and execution of post-market In Vitro Diagnostic Regulations activities through medical assessments of LD products, including through contribution to post-market surveillance activities in alignment with LD policies and procedures and applicable standards/regulations. Serve as a medical consultant to project teams for the preparation of IVDR performance evaluation reports. Other responsibilities may include advising on medical risks and benefits to evaluate product safety and effectiveness in laboratory medicine in support of functional group activities for commercialized products as well as for new product development activities. Reports directly to Siemens LD 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. Ability to create a standard operating procedure and tracking system for, compose and perform literature-based searches to identify potential product risks across all LD product lines, including hardware, software, and assays.
• 3. Actively collaborate with cross-functional key stakeholders (Commercial Product Quality, Risk Management, Clinical Affairs, etc.) in support of post-market surveillance plan and report creation to assess the safety, effectiveness, and performance of our regulated products/devices.
• 4. Maintains accurate documentation and files related to risk-benefit analyses and/or post-market surveillance activities.
• 5. Interacts directly with regulatory, clinical, marketing, manufacturing, 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.
• 6. Critically reviews analytical and clinical performance data and reports and provides an assessment of overall scientific and clinical/medical validity.

B. Critical Problem Thinking:

• 1. Ability to understand functionality/intended use of complex medical devices.
• 2. Proactive attitude with a logical, data-driven approach to problem-solving.
• 3. Performs special assignments and provides technical and clinical advice in the area of expertise.
• 4. Preempts potential problems via post-market surveillance and provides effective input to potential safety impact of identified risks.

C. Education:

M.D., Ph.D. or M.D./Ph.D. in related areas with practical experience in clinical pathology preferred. An equivalent combination of relevant education and experience, such as a master's 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 are preferred.

D. Experience:

• 1. Typically 3 to 5 years of successful experience in related laboratory medicine or medical device field.
• 2. Knowledge of laboratory diagnostic products market.
• 3. Experience in post-market surveillance and scientific literature searches.
• 4. Experience with ISO13485/2016 and/or IVDR EU 2017/746 is highly desirable.

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