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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 / Senior Project Manager, Clinical Evaluation - Abbott, Santa Clara Onsite

Lead clinical evaluation writing and project management for Abbott Vascular’s minimally invasive products. Prepare clinical evidence and EU regulatory submissions supporting vascular disease products.

USUnited StatesCACaliforniaMNMinnesotaOn-siteFull-timeSeniorEnglish RequiredClinical Operations

Description

  • Develop and maintain Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs, regulatory responses, and related documentation independently.
  • Source, assess, and summarize clinical evidence from investigations, literature, post-market surveillance, risk activities, and post-market clinical evaluations.
  • Analyze clinical results for product applications and regulatory submissions.
  • Build, manage, and support 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.
  • Lead or assist with responses to Notified Body questions.
  • Coordinate document communications across Regulatory Affairs, engineering, A&P, Marketing, Library Services, Quality Engineering, Post-market Surveillance, Clinical Affairs, Risk Management, Program Management, CROs, medical writers, and physician reviewers.
  • Advise strategically on regulatory requirements for clinical data and evaluations.
  • Support internal and external audits, audit responses, root cause analyses, corrective and preventive actions, effectiveness monitoring, and quality metrics.
  • Make independent decisions on regulatory matters related to Clinical Evaluation Reports.
  • Deliver projects within established budget guidelines.

Requirements

  • Bachelor’s degree required.
  • Education and experience in a scientific, research, engineering, or medical discipline.
  • 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 guidance, SSCPs, PMCF plans and reports, and relevant international standards for medical devices, clinical studies, and quality systems.
  • Experience managing projects.
  • Excellent writing, speaking, and presentation abilities in clinical or technical settings.
  • Strong command of medical and surgical terminology.
  • Ability to adjust effectively to changing priorities and competing demands.
  • Track record of producing high-quality work under tight deadlines.
  • Highly developed interpersonal skills and meticulous attention to detail.
  • Willingness to travel as needed.

Benefits

  • Career growth opportunities with an international company.
  • Free medical coverage through the Health Investment Plan PPO medical plan for eligible employees.
  • Retirement savings plan with a substantial employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit.
  • Equal Opportunity Employer.

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