Medical Writer IVRemote

Title: Medical Writer IV

Location: Santa Clara, CA | St. Paul, MN | Maple Grove, MN | Plano, TX / Remote

Duration: 12 Months

Job Overview:

We are seeking an experienced Medical Writer IV to support the Regulatory Clinical Evaluation team for Vascular Medical Devices. This role is responsible for developing and maintaining Clinical Evaluation Reports (CERs) and related regulatory documentation throughout the product lifecycle. The ideal candidate will have extensive medical writing experience within the medical device, pharmaceutical, clinical research, or healthcare industry.

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.

Required 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).

Preferred Qualification:

• CER writing experience.
• Background in Biomedical Sciences, Life Sciences, or a related field.
• Knowledge of ISO 13485, ISO 14155, ISO 14971, MDR, and FDA regulations.

Additional Information:

• Candidates can work onsite at one of the listed Abbott locations.
• Fully remote candidates may be considered; however, they must reside near an Abbott facility to obtain company equipment.
• Remote contractors are eligible for contingent positions but may not be eligible for FTE conversion.
• Candidates outside the Pacific Time Zone should be flexible for occasional meetings after 5 PM PST.

Apply today if you have strong Clinical Evaluation Reporting (CER) experience and a proven background in medical writing for medical devices, clinical research, or regulatory submissions.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.