Associate Medical Director, Medical Affairs

Abbott • Lake Forest, CA

1d • Hybrid

About The Position

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.

Requirements

• Bachelors Degree with some advanced degree in Clinical laboratory science.
• An equivalent combination of education and work experience
• Minimum 5 years Clinical laboratory experience
• Minimum 10 years Related work experience.
• Strong clinical judgment and a solid understanding of product development, risk management, and regulatory requirements within the healthcare or diagnostic industry.
• Ability to evaluate clinical and product performance data and translate findings into actionable recommendations.
• Ability to assess safety risks and clinical benefit-risk profiles throughout the product lifecycle.
• Ability to apply knowledge of post-market surveillance, medical device reporting (MDR), clinical research, and regulatory requirements.
• Ability to work effectively across scientific, technical, and business functions.
• Ability to communicate complex medical and scientific information to both technical and non-technical audiences.
• Ability to balance patient safety, regulatory compliance, clinical value, and business objectives when making recommendations.

Nice To Haves

• Advanced degree may offset required years of experience.
• Doctorate Degree (± 19 years)
• Advanced degree, MD preferred.
• Experience in Laboratory settings in a healthcare environment is ideal.
• Clinical experience as NP, MD, or DO.

Responsibilities

• 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.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level