Medical Writer / Clinical Evaluation Reporting (CER) – Medical Devices
Locations: Maple Grove, MN | St. Paul, MN | Sylmar, CA | Pleasanton, CA | Burlington, MA | Atlanta, GA | Santa Clara, CA
Category: Medical and Clinical Affairs
Platform: ThePharmaDaily.com – Global Life Sciences Job Portal
Abbott is seeking an experienced Medical Writer specializing in Clinical Evaluation Reporting (CER) to support regulatory and clinical documentation activities across its global medical device portfolio. This position offers the opportunity to contribute to high-impact work across the Heart Failure, Vascular and Cardiac Rhythm Management product lines. This is an on-site opportunity available across multiple U.S. locations.
This posting has been rewritten in a SEO-enhanced, GEO-targeted and GPT-optimized format for maximum visibility and candidate engagement on ThePharmaDaily.com.
Abbott is a globally recognized healthcare leader delivering advanced technologies across diagnostics, medical devices, nutrition and branded generic medicines. With more than 114,000 employees across 160+ countries, Abbott is committed to improving patient lives through innovation.
Abbott’s medical device technologies support better heart health, enhanced mobility for those with chronic pain and advanced diabetes care solutions. Every day, these technologies help improve outcomes for thousands of patients globally.
The Medical Writer / CER Specialist will provide strategic and technical writing expertise throughout the lifecycle of Abbott medical devices. This includes authoring and managing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), regulatory responses and related clinical documentation.
The ideal candidate brings hands-on experience in scientific or medical writing within regulated environments and possesses strong analytical, research and communication skills. Experience in clinical study design, quality engineering or risk management is highly beneficial.
Author and contribute to Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs and other regulatory documentation.
Evaluate and summarize clinical evidence from clinical studies, scientific literature, post-market surveillance data and risk management files.
Analyze scientific and clinical results to support regulatory submissions and product lifecycle requirements.
Collaborate with cross-functional teams including Regulatory Affairs, Clinical Affairs, Quality Engineering, Risk Management, Product Performance and Medical Affairs.
Identify and interpret relevant clinical and scientific data sources including literature, investigation results and medical references.
Review IFUs, patient guides, training materials and risk files to ensure consistency in risk communication.
Support responses to regulatory queries and Notified Body requests.
Maintain high standards of documentation quality, accuracy and compliance with regulatory frameworks including ISO 13485, ISO 14155, MDR, MEDDEV 2.7.1 and FDA guidance.
Contribute to regulatory submissions, risk assessments and product performance reviews.
Bachelor’s degree in a scientific, technical or health-related discipline, or an equivalent combination of experience and education.
Minimum 3 years of technical writing experience in a medical, scientific, biotechnology or high-technology environment.
Strong written and verbal communication skills with the ability to distill complex scientific concepts clearly.
Proven ability to manage multiple projects, prioritize workload and meet strict deadlines.
Experience working in matrixed and geographically diverse teams.
Strong organizational skills and attention to detail.
Advanced degree in biomedical engineering, life sciences, medicine, nursing or a similar field.
3+ years of medical writing experience in medical devices or pharmaceuticals, including CER writing.
Experience in experimental design, data interpretation and regulatory documentation.
Familiarity with medical device quality systems and regulatory standards.
Proficiency with Microsoft Office tools.
Experience in clinical research, complaint handling or diagnostic instrumentation.
Base Salary Range: $60,000 – $120,000
Compensation may vary by location and experience level.
Abbott offers comprehensive benefits including:
Career development and training programs
Competitive compensation and incentive structures
Healthcare, dental, vision and wellness benefits
Retirement plans with employer contribution
Tuition reimbursement and education assistance programs
Learn more at abbottbenefits.com.
Abbott is an Equal Opportunity Employer committed to fostering a diverse and inclusive workforce.
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