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Abbott
Abbott
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Abbott is a global healthcare company developing technologies and products across diagnostics, medical devices, nutrition, and branded generic medicines. Its portfolio includes FreeStyle Libre glucose monitoring systems and BinaxNOW rapid antigen tests, serving patients and healthcare professionals in areas such as diabetes management, infectious disease, and nutrition. Abbott’s work also focuses on expanding access to care, supporting health equity, and addressing challenges including malnutrition and infectious diseases. For professionals exploring healthcare careers, the company offers opportunities to contribute to medical innovation across a broad range of health-related disciplines.
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Senior Medical Writer and Project Manager, Clinical Evaluation (Onsite)

Develop clinical evaluation submissions and regulatory responses for Abbott Vascular’s minimally invasive medical devices. Lead medical writing and project coordination activities that support clinical evidence assessment and regulatory compliance.

USUnited StatesCACaliforniaMNMinnesotaOn-siteFull-timeSeniorEnglish RequiredClinical Operations

Description

  • Develop and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance documents, regulatory responses, and related records.
  • Assess and summarize clinical evidence from investigations, scientific literature, post-market surveillance, risk activities, and post-market clinical evaluations.
  • Analyze clinical results for product applications and regulatory submissions.
  • Build, oversee, or contribute to deliverable schedules using project management tools.
  • Coordinate timelines, project risks, and mitigation plans with cross-functional teams and medical writers.
  • Interpret clinical, scientific, risk, and literature data for product applications.
  • Contribute to or lead responses to questions from Notified Bodies.
  • Coordinate communication and document exchange between internal stakeholders and external vendors.
  • Advise on regulatory requirements governing clinical data and evaluations.
  • Support internal and external audits, audit responses, root cause investigations, corrective and preventive actions, effectiveness monitoring, and quality metrics.
  • Independently address regulatory matters related to Clinical Evaluation Reports.
  • Deliver projects within approved budget parameters.

Requirements

  • Bachelor’s degree required.
  • Academic and professional background in science, engineering, medicine, or a related research discipline.
  • Working knowledge of research design, methodology, and statistics.
  • Comprehensive knowledge of EU MDR 2017/745, MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev 4, MDCG clinical evaluation guidance, SSCP, PMCF plans and reports, and applicable international harmonized standards and guidelines.
  • Experience managing projects.
  • Strong writing, speaking, and presentation abilities in clinical and technical contexts.
  • Advanced knowledge of medical and surgical terminology.
  • Adaptability when priorities and competing demands change.
  • Track record of producing high-quality work under demanding deadlines.
  • Highly developed interpersonal skills and careful attention to detail.
  • Willingness to travel as required.

Benefits

  • Professional development opportunities with an international company offering long-term career growth.
  • Free medical coverage through the Health Investment Plan PPO medical plan for eligible employees in the following calendar year.
  • Retirement savings plan featuring a substantial employer contribution.
  • Tuition reimbursement assistance.
  • Freedom 2 Save program for employees managing student debt.
  • FreeU education support toward a bachelor’s degree.
  • Recognition as a leading employer in numerous countries worldwide.
  • Equal Opportunity Employer.

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