Medical Device Compliance Specialist
hace 3 semanas
Job Summary:
Fulfill medical device regulations in the region, ensuring compliance with ISO13485 and other relevant requirements for designated complaint handling units. Investigate moderately complex complaints, manage customer relationships, and escalate as necessary.
Key Responsibilities:
- Evaluate events to determine reportability to regulatory bodies
- Manage customer expectations during complaint investigations and resolution processes
- Assess complaint information, conduct additional investigations, and seek input from relevant departments
- Prepare and submit reports to competent authorities
- Summarize findings, formulate conclusions, and prepare final customer correspondence
Requirements:
- Bachelor's Degree in a related field
- 3 years of experience in complaint handling or a related field
- Experience working in a medical device or healthcare environment
What We Offer:
- Competitive compensation and benefits package
- Flexible working hours and remote working options
- Pension plan, life insurance, and medical plan
- Meal vouchers, service awards, and enhanced leave benefits
- Employee stock purchase program and employee assistance program
- Comprehensive wellness program
About Edwards Lifesciences:
As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a dynamic and friendly work environment. We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally.
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