Senior Medical Writer, Clinical Evaluation (on-site)

Senior Medical Writer, Clinical Evaluation Locations: Maple Grove, MN; St. Paul, MN; Plymouth, MN; Plano, TX; Santa Clara, CA.
Responsibilities Author and contribute to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and related documentation.
Evaluate and summarize clinical evidence from investigations, literature, post‑market surveillance, risk, and other sources.
Analyze results to prepare product applications and submissions.
Collaborate with team members and stakeholders in planning and supporting CER projects and processes.
Support additional clinical, regulatory, quality, and engineering deliverables as assigned.
Communicate and collaborate with Sales & Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group, Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs to complete project deliverables.
Maintain knowledge of assigned products and identify relevant data sources, interpreting and incorporating information from literature, clinical data, and medical references.
Review IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Reports and Plans (CER/CEP), physician training materials to ensure risk alignment.
Respond to complex queries from notified bodies and stakeholders.
Author necessary documents for regulatory submissions, communications, risk reviews, and regulatory inquiries.
Ensure quality and consistency of all deliverables with attention to detail and data integrity.
Ensure compliance with corporate, divisional, and regulatory policies including ISO13485, ISO14155, ISO14791, MEDDEV2.7.1, MDR, EU, and FDA guidance and Abbott SOPs and DOPs.
Required Qualifications Bachelor’s degree in Science, Medical Technology or equivalent technical degree, OR equivalent combination of education and work experience.
Minimum 3years of relevant experience in R&D, Technical Product Development, or Quality in a healthcare industry.
Comprehensive written and verbal communication, interpersonal, presentation, analytical, and project‑management skills.
Ability to prioritize and manage multiple projects simultaneously to meet deadlines.
Experience writing, editing, and managing engineering and technical documentation for new and existing products.
Proficiency in Word, Excel, PowerPoint, Outlook, and related tools.
Experience in complaint handling or operation/service of diagnostic instrumentation or medical technology.
Preferred Qualifications Advanced degree in science, biomedical engineering, medicine, nursing or similar health‑related discipline.
Experience in experimental design, data interpretation, and summarizing clinical data.
Knowledge of division products and quality systems and metrics.
3+years of medical writing experience in the medical device or pharmaceutical industry OR 7+years general technical writing with CER writing experience.
Experience in clinical research, product development, or quality in a healthcare industry context.
Strong analytical skills and time‑management ability.
Compensation Base pay: $78,000.00 – $156,000.00 (may vary by location).
Equal Opportunity Employer Abbott is an Equal Opportunity Employer, committed to employee diversity.

#J-18808-Ljbffr