POSITION SUMMARY

• Provides daily business operations support to Medical Affairs activities for product development as well as on-market activities related to new EU In Vitro Diagnostics Regulations (IVDR).

MAIN RESPONSIBILITIES

• Provide medical and scientific information for Abbott products and products in development and ensure that medical information is of high quality and communicated in an accurate, balanced, timely, and compliant way.
• Review Scientific Validity Reports, Performance Evaluations, Post Market Surveillance Reports, and Risk Management Files and provide medical input into documents to align with IVD-R requirements.
• Provide medical input into clinical study protocols.
• Develops initial medical opinions, medical platform documents and Health Hazard Assessments for review by medical directors.
• Works collaboratively with internal stake holders and manager to evaluate opportunities to address medical needs and provide medical input as needed.
• Travel: minimal (up to 5%)

ACCOUNTABILITY

• Provides Medical Affairs input at project level.
• Work is reviewed by IVDR Medical Affairs Manager(s) prior to approval.
• Provides timely responses to prevent delay is project timelines.
• Responsible for implementing and maintaining the effectiveness of the quality system.

REQUIRED QUALIFICATIONS:
EDUCATION:

• MD (clinical experience preferred) or PhD, 3(+) years industry experience

SKILLS:

• Critical review of product performance data
• Knowledge of the design control process
• Knowledge of the use of laboratory tests in patient care
• Ability to communicate medical issues and work collaboratively across all cross-functional areas
• Identify and highlight potential patient safety issues

PREFERRED EXPERIENCE, EDUCATION, ETC.:

• Above clinical work experience from any of the following: hospital lab, clinical lab (highly preferred), or hospital-affiliated research university lab.