Medical Device Compliance Specialist
hace 6 días
We are seeking a highly skilled Medical Device Compliance Specialist to join our team at Edwards Lifesciences in Spain. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with medical device regulations and guidelines.
Key Responsibilities- Investigate complaints and evaluate events to determine reportability to regulatory bodies.
- Manage customer relationships and expectations during complaint investigations and resolution processes.
- Assess complaint information, conduct additional investigations as needed, and escalate issues appropriately.
- Seek input from cross-functional teams, including Product Safety, Engineering, and Quality Assurance.
- Prepare and submit reports to regulatory authorities, after review by senior team members.
- Summarize findings, formulate conclusions, and prepare final customer correspondence.
- Plan and lead meetings to discuss complaint issues with affected functions.
- Identify problems and lead projects to improve processes, procedures, and practices.
- Bachelor's Degree in a related field.
- 3 years of experience in complaint handling or a related field.
- Experience working in a medical device, healthcare, or related environment.
- Proven expertise in MS Office Suite and general office machinery.
- Excellent written and verbal communication skills, and interpersonal relationship skills.
- Demonstrated problem-solving, critical thinking, and investigative skills.
- Full knowledge and understanding of Edwards Lifesciences 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.
- Ability to work in a team environment, including inter-departmental teams.
- Competitive compensation and benefits package.
- Flexible working hours and remote working options.
- Pension plan.
- Life insurance.
- Medical plan.
- Meal vouchers.
- Service awards.
- Enhanced leave benefits.
- Employee stock purchase program.
- Employee assistance program.
- Comprehensive wellness program.
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