Medical Writer / Clinical Evaluation Reporting (CER) – Medical Devices
Category: Medical and Clinical Affairs
Locations Available: Maple Grove, MN | St. Paul, MN | Sylmar, CA | Pleasanton, CA | Burlington, MA | Atlanta, GA | Santa Clara, CA
About Abbott
Abbott is a global healthcare leader dedicated to improving lives through advanced medical technologies, diagnostics, nutritionals, and branded generic medicines. With more than 114,000 employees across over 160 countries, Abbott delivers innovative solutions that support better health outcomes at every stage of life.
Abbott’s medical device portfolio includes technologies that support cardiovascular care, diabetes management, chronic pain therapies, and movement disorder treatments. These solutions enhance the quality of life for millions of patients worldwide.
Position Overview
Abbott is seeking a Medical Writer / Clinical Evaluation Reporting (CER) Specialist to join the Regulatory Clinical Evaluation team. This on-site role is available across multiple U.S. locations. The position supports the development of clinical evaluation documentation for Heart Failure, Vascular, and Cardiac Rhythm Management medical devices.
This role requires strong scientific writing capabilities, experience interpreting clinical evidence, and a solid understanding of medical device regulatory requirements.
Key Responsibilities
Develop and author Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs), regulatory responses, and related documentation
Analyze and summarize clinical evidence from clinical investigations, scientific literature, post-market surveillance data, product risk assessments, and post-market clinical follow-up reports
Collaborate with cross-functional teams including Regulatory Affairs, Clinical Affairs, Risk Management, Quality Engineering, Product Performance Group (PPG), and Marketing Library Services
Maintain deep familiarity with assigned medical device products and identify relevant data sources
Review and ensure alignment across risk management files, Instructions for Use (IFUs), patient guides, clinical protocols, and CER documentation
Support complex regulatory queries and communications with Notified Bodies and global regulatory authorities
Contribute to regulatory submissions, risk reviews, and clinical evaluation workflows
Ensure accuracy, consistency, and regulatory compliance in all written deliverables
Adhere to global regulatory standards including ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and applicable FDA and EU guidance
Ensure documentation aligns with Abbott SOPs, divisional policies, and quality expectations
Required Qualifications
Bachelor’s degree in a relevant scientific, biomedical, engineering, or technical discipline; or an equivalent combination of education and experience
Minimum 3 years of experience as a technical or medical writer in a medical device, biotechnology, or high-technology environment
Strong written and verbal communication skills with expertise in scientific interpretation and document preparation
Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment
Strong analytical, organizational, and documentation skills
Ability to work independently and collaboratively in a matrixed, geographically diverse organization
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and similar tools
Preferred Qualifications
Advanced degree in science, biomedical engineering, nursing, medicine, or a related discipline
3+ years of medical writing experience in medical devices or pharmaceuticals, including CER development
Experience in medical device quality systems, risk management, and regulatory submissions
Working knowledge of experimental design, data interpretation, and literature analysis
Experience in complaint handling, technical support, or operation of diagnostic instrumentation
Strong understanding of medical technologies and regulatory requirements for device documentation
Compensation
Base Salary Range: USD 60,000 – 120,000
(Specific pay range may vary by location.)
Why Join Abbott
Abbott offers a comprehensive total rewards package, including:
Career development and training programs
Competitive compensation and incentive structures
Medical, dental, vision, wellness, and occupational health benefits
Tuition assistance and education programs
Paid time off and work-life balance support
401(k) with a generous company match
Strong financial stability and global reputation
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