Medical Writer IV – Regulatory CERs (Remote)

Abbott; Illinois; Remote; USD 110,000 - 150,000; Full time

Job summary

Abbott is seeking a Medical Writer IV to support Regulatory Clinical Evaluation for vascular medical devices. This role involves developing and maintaining Clinical Evaluation Reports (CERs) and related regulatory documentation across the product lifecycle.

The ideal candidate has extensive medical writing experience in medical devices or related fields, with strong collaboration across Regulatory Affairs, Clinical Affairs, Quality Engineering, R&D, and Medical Affairs to ensure compliant

Qualifications

• Bachelor's Degree or equivalent combination of education and experience.
• 6-8 years of medical writing experience in the medical device, pharmaceutical, clinical research, healthcare, or related industry.
• Alternatively, 8+ years of technical writing experience.
• Strong experience authoring scientific, clinical, regulatory, or technical documentation.
• Excellent written, verbal, analytical, and organizational skills.
• Experience working in cross-functional environments.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Author Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), SSCPs, regulatory responses, and related documentation.
• Evaluate and summarize clinical evidence from clinical investigations, literature reviews, post-market surveillance activities, risk management files, and PMCF data.
• Analyze clinical data and prepare documentation supporting regulatory submissions and product approvals.
• Collaborate with cross-functional teams including Regulatory Affairs, Clinical Affairs, Quality Engineering, R&D, Risk Management, Medical Affairs, Sales & Marketing, and Product Performance Groups.
• Review and maintain consistency across IFUs, patient guides, risk management documentation, PMS plans, PMCF reports, CERs, and physician training materials.
• Support responses to notified bodies, regulatory agencies, and stakeholder inquiries.
• Ensure compliance with applicable regulations, guidance documents, and quality standards.

Skills

Medical writing

Regulatory writing

Cross-functional teams

Communication skills

MS Office

Education

Bachelor's degree

Tools

Microsoft Office Suite

Job description

Abbott is seeking a Medical Writer IV to support Regulatory Clinical Evaluation for vascular medical devices. This role involves developing and maintaining Clinical Evaluation Reports (CERs) and related regulatory documentation across the product lifecycle.

The ideal candidate has extensive medical writing experience in medical devices or related fields, with strong collaboration across Regulatory Affairs, Clinical Affairs, Quality Engineering, R&D, and Medical Affairs to ensure compliant