Compliance Specialist
hace 7 días
We are seeking a highly skilled Compliance Specialist to join our team at Edwards Lifesciences in Spain. As a Compliance Specialist, you will be responsible for ensuring that our medical devices comply with all applicable regulations and standards.
Key Responsibilities- Investigate complaints and evaluate events to determine if they qualify as a complaint.
- Manage customer relationships and expectations during the complaint investigation and resolution process.
- Assess complaint information and conduct additional investigations as needed.
- Evaluate complaints for Medical Device Reporting to competent authorities.
- Prepare and submit reports to Competent Authorities.
- Summarize findings and formulate conclusions.
- Prepare and submit final customer correspondence.
- May plan agenda for and run meetings to discuss complaint issues with affected functions.
- Identify problems and lead projects to improve processes, procedures, and/or practices.
- Bachelor's Degree in a related field.
- 3 years of experience in complaint handling or a similar field.
- Experience working in a medical device or healthcare environment.
- Proven expertise in MS Office Suite.
- Excellent written and verbal communication skills.
- Interpersonal relationship skills.
- Problem-solving, critical thinking, and investigative skills.
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance.
- Good knowledge of medical terms and human anatomy.
- Full knowledge of Medical Device Vigilance regulations, and regulatory reporting regulations.
- Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing.
- Ability to manage confidential information with discretion.
- Attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast-paced environment.
- Competitive Compensation and Benefits package.
- Flexible working hours, remote working.
- Pension plan.
- Life Insurance.
- Medical plan.
- Meal Vouchers.
- Service Awards.
- Enhanced Leave benefits.
- Employee Stock Purchase Programme.
- Employee Assistance Programme.
- Comprehensive Wellness programme.
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