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Director, Medical Affairs

5 years
Not Disclosed
10 Nov. 19, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director, Medical Affairs

Location: United States (Remote)
Category: Medical and Clinical Affairs

Company Overview

Abbott is a global leader in healthcare innovation, delivering advanced technologies across diagnostics, medical devices, nutrition, and branded generic medicines. With a presence in more than 160 countries and a workforce of over 114,000 professionals, Abbott is committed to improving health and quality of life at every stage.

Why Work at Abbott

At Abbott, you build a career that makes a meaningful impact. Employees benefit from:
• Comprehensive career development opportunities within a global organization
• Eligibility for free medical coverage under the Health Investment Plan (HIP) PPO
• Competitive retirement savings programs with strong employer contributions
• Tuition reimbursement and education benefits including FreeU and Freedom 2 Save
• Recognition as one of the world’s most admired and inclusive employers
• A supportive environment for professional growth, diversity, and work-life balance


Position Overview

The Director of Medical Affairs will support Abbott’s Heart Failure (HF) business, which focuses on hemodynamic monitoring and mechanical circulatory support devices. This role is responsible for providing medical leadership across product development, clinical research, product quality, compliance, commercial strategy, and healthcare professional engagement.

The Director will report directly to the Chief Medical Officer and act as a key medical representative for internal teams, regulatory agencies, customers, and professional societies.


Key Responsibilities

Medical Strategy and Leadership

• Develop medical assessments, medical platforms, and Health Hazard Assessments.
• Provide medical guidance for promotional and commercial initiatives.
• Serve as the medical representative on Risk Evaluation teams.
• Support investigation teams with medical insights as required.
• Update medical affairs procedures and submit change requests when necessary.
• Provide medical direction for MDR reporting.

Quality, Compliance, and Regulatory Support

• Provide initial medical content for regulatory and quality communications, technical bulletins, and directives.
• Offer medical expertise to customer-facing quality responses and documentation.
• Support activities related to professional education and scientific communication.

Research and Clinical Activities

• Regionally oversee Investigator-Initiated Studies (IIS) and Research Grant programs.
• Assist in the development and evaluation of clinical research strategies.
• Provide medical input for new product development initiatives.

Stakeholder Engagement

• Engage directly with clinicians, customers, and healthcare professionals as needed.
• Document and manage off-label discussions according to compliance requirements.
• Assist the Chief Medical Officer with Key Opinion Leader (KOL) interactions and professional society collaboration.


Qualifications and Experience Required

Education

MD strongly preferred; a PhD in a relevant medical or scientific field may be considered.

Experience Required

• Minimum 5 years of clinical experience, including experience in cardiovascular medicine.
• Proven expertise in clinical research, data interpretation, and scientific communication.
• Strong presentation, communication, and stakeholder engagement skills.
• Experience in the medical device or healthcare sector is beneficial.

Additional Requirements

• Remote position based in the United States.
• Ability to travel up to 70 percent.