Title: Associate Medical Director, Medical AffairsThe OpportunityThis position works out of our
Conway Park, IL or
Irving, TX location in the
Core Lab Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
The
Associate Medical Director, Medical Affairs provides medical, scientific, and clinical expertise to support the development, regulatory approval, commercialization, and post-market performance of diagnostic products. This role serves as a key medical resource for product development teams and helps ensure product safety, clinical effectiveness, and regulatory compliance throughout the product lifecycle.
Working closely with R&D, Clinical Affairs, Regulatory Affairs, Quality, and Product Development teams, you will evaluate product performance data, assess safety signals, support clinical studies, and provide medical oversight for product risk management activities. You will also contribute to medical strategy and help ensure that clinical and scientific considerations are incorporated into business decisions.
We're seeking a medical professional with strong clinical judgment and a solid understanding of product development, risk management, and regulatory requirements within the healthcare or diagnostic industry.
Successful candidates will be able to:
- Evaluate clinical and product performance data and translate findings into actionable recommendations.
- Assess safety risks and clinical benefit-risk profiles throughout the product lifecycle.
- Apply knowledge of post-market surveillance, medical device reporting (MDR), clinical research, and regulatory requirements.
- Work effectively across scientific, technical, and business functions.
- Communicate complex medical and scientific information to both technical and non-technical audiences.
- Balance patient safety, regulatory compliance, clinical value, and business objectives when making recommendations.
What You'll Work On- Provide medical and scientific support for new product development programs, from concept through commercialization.
- Provides medical support to the Office of the Chief Medical Officer that includes representing the Division at Medical Conferences, Sales Meetings and Physician/Hospital interactions, as required by the DVP or CMO.
- Partner with Medical Directors to develop medical assessment documents, scientific reviews, medical opinions, and clinical evidence summaries.
- Serve as a clinical subject matter expert by providing guidance on laboratory medicine, diagnostic testing practices, healthcare workflows, and customer needs.
- Support design control and product development activities by ensuring clinical and medical requirements are appropriately incorporated into product design.
- Evaluate clinical risks associated with new products and technologies and provide recommendations to support safe and effective product development.
- Participate in medical oversight activities related to product performance, post-market surveillance, and patient safety.
- Review and assess product complaints, Medical Device Reports (MDRs), adverse event trends, and other post-market data to identify potential safety concerns.
- Conduct or support Health Hazard Evaluations (HHEs), medical risk assessments, and benefit-risk analyses.
- Partner with Quality and Regulatory Affairs teams to investigate product performance issues and determine appropriate corrective actions.
- Develop and support processes that strengthen medical risk management and product safety monitoring across the product lifecycle.
- Provide medical input into clinical study design, protocol development, and clinical risk mitigation strategies.
- Review clinical data and product performance information to support regulatory submissions and post-market activities.
- Serve as a medical resource for interactions with regulatory agencies, including the FDA and international health authorities.
- Support compliance with global regulations, quality standards, and medical device reporting requirements.
- Recommend enhancements to product monitoring processes, safety assessments, and risk evaluation methodologies.
- Assess the clinical significance of product performance findings and their potential impact on patients, healthcare providers, and laboratory operations.
- Present medical assessments, risk evaluations, and scientific recommendations to leadership and cross-functional stakeholders.
- Represent Medical Affairs at scientific meetings, customer interactions, physician engagements, industry conferences, and internal business meetings as needed.
Required Qualifications- Bachelors Degree with some advanced degree in Clinical laboratory science.
- Advanced degree may offset required years of experience.
- An equivalent combination of education and work experience Doctorate Degree (± 19 years) Advanced degree, MD preferred.
- Minimum 5 years Clinical laboratory experience
- Minimum 10 years Related work experience.
Preferred Qualifications- Experience in Laboratory settings in a healthcare environment is ideal.
- Clinical experience as NP, MD, or DO.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/
The base pay for this position is $129,300.00 - $258,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Medical & Scientific Affairs
DIVISION:CRLB Core Lab
LOCATION:United States > Lake Forest : CP01
ADDITIONAL LOCATIONS:United States > Irving : LC-02
WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:Yes
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work requiring repeated bending, stooping, squatting or kneeling, Work with human blood or other potentially infectious materials, Work with infectious organisms or known infectious materials, Work with or near radiation sources and/or radioactive material
