[Hiring] Medical Writer II @Abbott

Role Description

The IVDR Medical / Clinical Evaluator is responsible for ensuring ongoing compliance with the European Union In Vitro Diagnostic Regulation (EU IVDR) through assessment and review of analyte-specific literature to determine its scientific performance and medical relevance to the Abbott device. This role supports regulatory submissions, audits, and the continuous improvement of Abbott’s Quality Management System (QMS) to ensure product safety, performance, and regulatory compliance across the product lifecycle.

Essential Job Functions

• Literature Surveillance and Assessment:
  • Conduct systematic reviews of analyte‑specific scientific and clinical literature to identify new or emerging information relevant to the safety, performance, and intended use of Abbott in vitro diagnostic devices.
  • Assess the relevance, quality, and applicability of identified literature to Abbott devices, including evaluation of study design, analyte characteristics, clinical context, and comparability to the Abbott assay and intended population.
  • Document literature assessments and conclusions to support IVDR post‑market surveillance activities, Performance Evaluation Reports (PERs), risk management updates, and regulatory submissions, collaborating with Clinical Affairs and Regulatory Affairs as required.
• Post-Market Surveillance (PMS):
  • Support IVDR-compliant post-market surveillance activities, including the collection, trending, and analysis of complaints, adverse events, and field performance data.
  • Monitor ongoing product safety and performance using real-world evidence, vigilance data, and scientific literature reviews.
• Data Review and Analysis:
  • Support clinical, statistical, and performance data reviews to support Performance Evaluation Reports (PERs) and technical documentation updates.
  • Partner with Clinical Affairs, R&D, and Data teams to ensure data accuracy, traceability, and documentation integrity.
• Cross-Functional Collaboration:
  • Collaborate with Regulatory Affairs, Quality, Clinical Affairs, and Manufacturing to ensure end-to-end compliance.
  • Provide IVDR surveillance subject-matter expertise, training, and guidance across Abbott diagnostic franchises.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, or a related scientific discipline.
• 3–5 years of experience in IVD or medical device post-market surveillance, regulatory affairs, quality, or clinical roles.
• Demonstrated working knowledge of EU IVDR, ISO 13485, ISO 20916, and post-market surveillance and vigilance requirements.
• Experience with PMS systems, vigilance reporting, and performance evaluation documentation.
• Strong analytical, technical writing, and communication skills.
• Proficiency with Microsoft Excel, data analysis tools, and electronic QMS platforms.

Preferred Qualifications

• Experience supporting IVDR Notified Body interactions and EU regulatory inspections.
• Familiarity with real-world evidence methodologies and systematic literature evaluations.
• Experience working within a global matrixed organization.

Benefits

• 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)