Clinical Evaluation Reporting / Medical Writer (CER) – Abbott
Location: Maple Grove, MN | St. Paul, MN | Santa Clara, CA
Work Mode: On-site
Salary Range: $60,000 – $120,000 (may vary by location)
Job Summary:
Abbott is hiring a Clinical Evaluation Reporting / Medical Writer (CER) to support the regulatory clinical evaluation team across its medical device divisions. In this on-site role, you will create clinical evaluation plans and reports for product submissions, collaborating across regulatory, clinical, and engineering teams. Ideal for candidates with 3+ years of experience in medical or technical writing in the medical device or pharmaceutical industry.
Key Responsibilities:
Author and contribute to Clinical Evaluation Plans, Clinical Evaluation Reports (CERs), SSCPs, and regulatory documents
Analyze and summarize clinical data, post-market surveillance reports, literature, and risk assessments
Collaborate with cross-functional teams including Clinical Affairs, Regulatory, Risk Management, and Quality
Support clinical and regulatory responses, submissions, and audits
Maintain comprehensive knowledge of product portfolios and relevant medical/scientific literature
Ensure document quality, consistency, and regulatory compliance (ISO13485, MDR, MEDDEV 2.7.1, FDA guidance)
Participate in responses to notified body queries and global regulatory requirements
Required Skills & Qualifications:
Bachelor's degree in science, engineering, or a healthcare discipline (advanced degree preferred)
3+ years of medical writing experience in pharma, biotech, or med device industry
Knowledge of EU MDR, MEDDEV 2.7.1, and other regulatory frameworks
Excellent skills in literature evaluation, clinical data interpretation, and CER writing
Strong project management, communication, and cross-functional collaboration skills
Proficiency in Microsoft Office Suite and clinical documentation tools
Experience in complaint handling, risk management, and product development is a plus
Perks & Benefits:
Competitive salary and comprehensive medical coverage
Generous 401(k) plan with high employer contribution
Tuition reimbursement and FreeU education program
Health Investment Plan (HIP) with potential for free coverage
Career advancement in a globally recognized medical device leader
Supportive, inclusive work culture with recognition for women, scientists, and diversity
Company Description:
Abbott is a global healthcare leader innovating across diagnostics, medical devices, pharmaceuticals, and nutrition. With over 114,000 employees in 160+ countries, Abbott develops life-changing technologies that help people live better, healthier lives. The company is consistently recognized as a top employer for diversity, innovation, and workplace excellence.
Work Environment:
On-site | Available in: Maple Grove, MN | St. Paul, MN | Santa Clara, CA
Call to Action:
Are you a skilled medical writer passionate about regulatory science and clinical research? Join Abbott to shape the future of global healthcare.
Apply now to make an impact through evidence-driven innovation.
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