Medical Writer IV - Clinical Evaluation Reporting (CER) - AF2026

Medical Writer IV – Clinical Evaluation Reporting (CER)

Location: Santa Clara, CA | St. Paul, MN | Maple Grove, MN | Plano, TX
Work Arrangement: Onsite; fully remote may be considered for qualified experienced contractors
Schedule: Monday–Friday, 8:00 AM–5:00 PM | 40 hours/week
Contract:Contingent/Contract
Start: ASAP, following completion of required screenings

About the Role

We are seeking an experienced Medical Writer IV / Clinical Evaluation Reporting (CER) Writer to support vascular medical device products.

This role is ideal for an experienced medical, scientific, clinical, regulatory, or technical writer who can translate complex clinical and scientific information into clear, accurate, and compliant regulatory documentation.

You will work closely with cross-functional teams including Clinical Affairs, Regulatory Affairs, Medical Affairs, Quality Engineering, Risk Management, R&D, Clinical Science, and Marketing to develop clinical evaluation documents and support regulatory submissions throughout the product lifecycle.

What You'll Do

• Author and contribute to Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, regulatory responses, and related documentation
• Evaluate and summarize clinical evidence from clinical investigations, scientific literature, post-market surveillance, risk management, and post-market clinical follow-up activities
• Analyze clinical and scientific data and incorporate findings into regulatory and product documentation
• Identify, research, and evaluate relevant medical and scientific literature and references
• Review and ensure consistency across IFUs, patient guides, risk management files, clinical evaluation documents, PMS/PMCF plans and reports, and physician training materials
• Support responses to complex regulatory questions and requests from notified bodies and other stakeholders
• Prepare and contribute to regulatory submissions, regulatory inquiries, risk reviews, and other clinical and regulatory deliverables
• Collaborate with cross-functional teams to plan and execute CER-related projects
• Maintain strong knowledge of assigned vascular medical device products and their clinical evidence
• Ensure accuracy, consistency, data integrity, and quality across all deliverables
• Ensure documentation complies with applicable regulations, standards, guidance, and company procedures

What We're Looking For

• Bachelor's degree or equivalent combination of education and work experience
• 6–8 years of medical writing experience within the medical device, pharmaceutical, clinical research, medical, or scientific industry
• OR 8+ years of general technical writing experience
• Strong experience writing and editing complex technical, medical, scientific, or regulatory documents
• Excellent written and verbal communication skills
• Strong analytical skills and ability to interpret complex clinical and scientific information
• Excellent organization and time-management skills
• Ability to manage multiple complex projects and deadlines
• Experience collaborating with cross-functional teams

Preferred Qualifications

• Background in Biomedical Sciences, Life Sciences, Medicine, or a related healthcare/scientific discipline
• Clinical Evaluation Report (CER) writing experience
• Experience with medical devices, preferably vascular devices
• Familiarity with regulatory and quality standards such as ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, EU MDR, and FDA guidance
• Experience with clinical evaluation, risk management, post-market surveillance, or post-market clinical follow-up
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook

Remote Work

Fully remote work may be considered for experienced contractors who live within reasonable proximity to an Abbott location and can travel to an Abbott facility when necessary to pick up company equipment.

Please note: Remote contractors cannot be converted to a full-time employee (FTE) while working remotely.

Candidates located outside Pacific Time may occasionally be required to attend meetings after 5:00 PM local time.

Why This Opportunity?

• Work on vascular medical device products with a major healthcare organization
• Contribute to clinical evaluation and regulatory documentation throughout the product lifecycle
• Collaborate with experienced professionals across clinical, regulatory, quality, engineering, and medical teams
• Opportunity to work on high-impact documentation supporting medical device safety, effectiveness, and regulatory compliance

Interested in making an impact through medical and regulatory writing? Apply today!

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.