Product Incident Risk Management Expert - Remote

Overview

We are seeking a detailed-oriented and experienced Product Incident Risk Management expert to lead health hazard evaluations and contribute to risk assessments for medical devices and in vitro diagnostics (IVDs).

In Short

• Lead health hazard evaluations for medical devices.
• Contribute to risk assessments and regulatory compliance.
• Conduct reviews of complaints and technical literature.
• Collaborate with cross-functional teams.
• Analyze product performance data.
• Ensure compliance with FDA and EU regulations.
• Monitor post-market safety signals.
• Assist clinical sponsors with safety reporting plans.
• Communicate clinical and diagnostic information effectively.
• Work remotely with a full-time schedule.

Requirements

• Bachelor's or master's in biomedical engineering or related field.
• 3-5 years' experience in health hazard evaluations.
• Knowledge of diagnostics in oncology or related areas.
• Excellent analytical and writing skills.
• Experience with regulatory compliance.
• Strong communication and presentation skills.
• Familiarity with safety databases.
• Ability to collaborate across teams.
• Understanding of human factors and use error analysis.
• Knowledge of ISO 14971 and international safety standards.

Benefits

• Competitive salary range with eligibility for bonuses.
• Stock options and comprehensive benefits.
• Opportunity to work in a dynamic and inclusive environment.
• Support for professional development and training.
• Flexible work arrangements with remote options.