Senior Medical Writer, Clinical Evaluation (on-site)

Abbott

Maple Grove, Minnesota, United States
Base: $78,000.00 – $156,00.00; bonus/equity: not s...
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Bachelor's degree in science or medical technology
3 years relevant experience in healthcare industry
Experience writing clinical evaluation reports
** Abbott is seeking a Senior Medical Writer for its Clinical Evaluation team, tasked with authoring clinical evaluation reports and ensuring compliance with regulatory standards. The position requires significant experience in medical writing and a background in healthcare, with a focus on technical documentation related to product development. **

Job Summary

  • The role provides technical and strategic writing expertise throughout the product development and life cycle process for medical devices.
  • Employees qualify for free medical coverage, a high employer contribution retirement plan, and tuition reimbursement benefits.
  • The position requires authoring Clinical Evaluation Plans/Reports and analyzing clinical evidence for regulatory submissions to notified bodies.

Matching Summary

Match Score: 75

** Abbott is seeking a Senior Medical Writer for its Clinical Evaluation team, tasked with authoring clinical evaluation reports and ensuring compliance with regulatory standards. The position requires significant experience in medical writing and a background in healthcare, with a focus on technical documentation related to product development. **

Salary

Base: $78,000.00 – $156,00.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's degree in Science or Medical Technology
  • 3 years relevant experience in healthcare industry
  • Experience writing Clinical Evaluation Reports
  • Knowledge of ISO13485 and MDR regulations
  • Strong written and verbal communication skills

Nice-to-have

  • Advanced degree in biomedical engineering or medicine
  • Experience with experimental design and data interpretation
  • Familiarity with Abbott division products
  • Cross-division business unit collaboration experience
  • Proficiency in developing spreadsheets for metrics

Key Requirements

  • Minimum 3 years relevant experience in R&D, Technical Product Development, or Quality
  • Bachelor's degree in Science, Medical Technology, or equivalent combination
  • Comprehensive knowledge of ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and FDA guidance

Work Rights

Not specified

Tailored Resume

Cover Letter