Senior Medical Writer – Clinical Evaluation (On-Site)
Location: Maple Grove, MN | Category: Medical & Clinical Affairs | Employment Type: Full-Time
Company Overview:
Abbott is a global healthcare leader, delivering innovative medical devices, diagnostics, nutritionals, and branded generics that improve lives worldwide. With over 114,000 colleagues in more than 160 countries, Abbott is committed to advancing healthcare through science, technology, and patient-centered solutions.
Role Overview:
Abbott’s Regulatory Clinical Evaluation team is seeking a Senior Medical Writer, Clinical Evaluation to join our Maple Grove, MN facility. This role provides technical and strategic writing expertise to support product development and lifecycle management. The Sr. Medical Writer will focus on authoring Clinical Evaluation Reports (CERs) and related regulatory documents for Neuromodulation, CAHF, and Vascular product lines.
Key Responsibilities:
Author and contribute to Clinical Evaluation deliverables including Clinical Evaluation Plans/Reports, PMS/PMCF Plans/Reports, SSCPs, Regulatory Responses, and related documentation.
Evaluate, analyze, and summarize clinical evidence from literature, clinical investigations, post-market surveillance, and risk assessments for regulatory submissions.
Collaborate with cross-functional teams including Sales & Marketing, R&D, Regulatory Affairs, Quality, Clinical Science, Risk Management, and Medical Affairs to support CER projects.
Review and align documentation such as IFUs, patient guides, risk management files, and training materials with regulatory and clinical requirements.
Ensure compliance with applicable corporate policies, SOPs, and regulations, including ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, EU and FDA guidance documents.
Maintain thorough knowledge of assigned products and relevant clinical, regulatory, and quality standards.
Provide high-quality documentation with attention to detail, accuracy, and consistency.
Required Qualifications:
Bachelor’s degree in Science, Medical Technology, or equivalent technical field OR equivalent combination of education and work experience.
Minimum 3 years’ experience in R&D, technical product development, or quality roles within healthcare or medical device industries.
Strong writing, editing, analytical, project management, and presentation skills.
Experience managing multiple projects and meeting tight deadlines.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Preferred Qualifications:
Advanced degree in Science, Biomedical Engineering, Medicine, Nursing, or related health discipline.
3+ years of medical writing experience in medical device or pharmaceutical industries, preferably including CER writing.
Experience with clinical study design, data interpretation, and summarizing clinical evidence.
Knowledge of medical device quality systems and regulatory processes.
Experience in complaint handling, diagnostic instrumentation operation, or medical technology.
Experience working in cross-functional, enterprise-level environments.
Compensation & Benefits:
Base pay: $78,000 – $156,000 (location-dependent).
Abbott provides comprehensive health and wellness benefits, retirement plans, tuition reimbursement, and career development programs.
Apply Now:
Advance your career as a Senior Medical Writer – Clinical Evaluation at Abbott and contribute to the development of life-changing medical devices and therapies.
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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