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About the Role

Edwards Lifesciences is a global leader in patient-focused medical innovations in structural heart disease and critical care monitoring. We provide medical technology to millions of patients in over 100 countries, focusing on improving treatment outcomes and creating sustainable solutions for unmet medical needs.

Responsibilities

• Manage clinical trial safety operations for medical devices, including post-marketing clinical trials, and lead reviews, oversight, and improvements.
• Collect adverse event and malfunction information, and review and make judgments on evaluation results.
• Review and make judgments on reporting safety information to regulatory authorities (PMDA) and clinical trial sites.
• Create and review safety-related documents.
• Manage and control the progress and quality of safety operations, and lead the improvement and standardization of business processes.
• Lead collaboration and coordination with global and related departments, and address issues.
• Manage and improve safety procedures, and conduct training.
• Review and evaluate safety data aggregation and analysis results, and conduct risk assessments.

Requirements

• Bachelor's degree in biology or life sciences, and 8+ years of practical experience in the medical industry (required).
• Master's degree or equivalent (preferred).
• 5+ years of Clinical Safety operations experience (medical devices or pharmaceuticals), OR 3+ years of Clinical Safety operations experience and 2 years of post-marketing safety management experience, OR 5+ years of clinical-related experience with TAVI (including experience reporting TAVI complaints).
• Knowledge of medical device regulations.
• English reading comprehension (TOEIC 700+).
• Knowledge of the cardiovascular field or TAVI products.
• Experience leading cross-functional projects.

Skills

• Clinical Safety operations
• Post-marketing safety management
• Medical device regulations
• English reading comprehension
• Cardiovascular field knowledge
• TAVI product knowledge
• Cross-functional project leadership
• Safety operations review/final judgment
• Global team coordination
• Business communication in English (email/meetings)
• PMDA consultation/inquiry response

Location

• Japan

Work Type

• Full-time

Experience Level

• 8+ years
• 5+ years
• 3+ years
• 2+ years

Education Level

• Bachelor's degree
• Master's degree

About the Company

• Edwards Lifesciences is a global leader in structural heart disease and critical care monitoring, driven by a passion to improve patient lives.
• Through breakthrough technologies, world-class evidence, and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.