Medical Writer – Clinical Evaluation Reporting (CER) | Abbott (On-site, USA)
Job Summary
Abbott is seeking a skilled Medical Writer specializing in Clinical Evaluation Reporting (CER) to join its global team of healthcare innovators. This on-site opportunity (Maple Grove MN, St. Paul MN, or Santa Clara CA) is ideal for professionals with strong experience in medical writing, clinical research, or risk management who are passionate about advancing medical technology and regulatory compliance in the medical device industry.
Key Responsibilities
Write and develop Clinical Evaluation Reports, Plans, SSCPs, and regulatory documentation
Analyze data from literature, post-market surveillance, and clinical studies
Collaborate with cross-functional teams: Regulatory, Clinical Affairs, Risk Management, Medical Affairs
Review and align risk documentation across IFUs, patient guides, protocols, etc.
Respond to complex queries from Notified Bodies and regulators
Ensure document compliance with ISO13485, MEDDEV 2.7.1, MDR, and FDA guidance
Support regulatory submissions, risk reviews, and clinical documentation needs
Required Skills & Qualifications
Bachelor’s degree in science, biomedical engineering, or related field
Minimum 3 years of technical/medical writing experience in healthcare, pharma, or medtech
Strong knowledge of CER writing, ISO standards, and MDR regulations
Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Strong verbal and written communication skills
Ability to work in a fast-paced, matrixed, and diverse team environment
Preferred Qualifications
Advanced degree (MS, PhD, MD, or equivalent)
3+ years of medical device industry writing experience
Experience in complaint handling or diagnostic instrumentation
Understanding of clinical research, product development, or regulatory strategy
Perks & Benefits
Base salary range: $60,000 – $120,000
Free medical coverage via Health Investment Plan (HIP) PPO
Excellent 401(k) with high employer contributions
Tuition reimbursement and FreeU education benefits
Global career advancement opportunities
Recognition as a top workplace for diversity and inclusion
Work on impactful products improving global healthcare
Company Overview
Abbott is a global healthcare leader with 114,000+ employees, delivering life-changing technologies in diagnostics, medical devices, branded generics, and nutritionals. With a presence in 160+ countries, Abbott helps people live more fully at every stage of life.
Work Mode:
On-site – Maple Grove MN, St. Paul MN, or Santa Clara CA
Call to Action
Are you a passionate medical writer ready to make a real impact in healthcare innovation? Apply today and take the next step in your regulatory writing career with a world leader in medical technology.
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