Medical Device Compliance Specialist
hace 1 día
We are seeking a highly skilled Medical Device Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a key member of our Quality Assurance department, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Investigate complaints and evaluate events to determine if they qualify as a complaint, manage customer relationships, and assess complaint information provided.
- Conduct additional investigations as needed, escalate as appropriate, and seek information and input from Product Safety, Engineering, and other departments/business units.
- Evaluate complaints for Medical Device Reporting to competent authorities, prepare and submit reports, and summarize findings.
- Plan agendas for and run meetings to discuss complaint issues with affected functions, identify assignable root cause, resolve open action items, and gather additional technical information.
- Identify problems and lead projects to improve processes, procedures, and/or practices, and recommend solutions.
- 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 a related environment.
- Proven expertise in MS Office Suite and ability to operate 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 and representing the department on specific projects.
- Ability to build productive internal/external working relationships.
Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, critical care, and surgical monitoring. We collaborate with leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
We offer a 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, and more.
-
Medical Device Compliance Specialist
hace 7 días
Valencia, Valencia, España Edwards Lifesciences A tiempo completoJob SummaryWe 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 ResponsibilitiesInvestigate complaints and evaluate events to determine...
-
Medical Device Compliance Specialist
hace 6 días
Valencia, Valencia, España Edwards Lifesciences A tiempo completoJob SummaryWe 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 ResponsibilitiesInvestigate complaints and evaluate events to determine...
-
Compliance Specialist
hace 7 días
Valencia, Valencia, España Edwards Lifesciences A tiempo completoJob SummaryWe 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 ResponsibilitiesInvestigate complaints and evaluate events to determine if they qualify as a...
-
Compliance Specialist
hace 7 días
Valencia, Valencia, España Edwards Lifesciences A tiempo completoJob SummaryWe 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 ResponsibilitiesInvestigate complaints and evaluate events to determine if they qualify as a...
-
Quality Compliance Specialist
hace 7 días
Valencia, Valencia, España Edwards Lifesciences A tiempo completoJob SummaryWe are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences in Spain. As a Quality Compliance Specialist, you will be responsible for ensuring that our medical devices comply with all applicable regulations and standards.Key ResponsibilitiesInvestigate complaints and evaluate events to determine if they...
-
Quality Compliance Specialist
hace 6 días
Valencia, Valencia, España Edwards Lifesciences A tiempo completoJob SummaryWe are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences in Spain. As a Quality Compliance Specialist, you will be responsible for ensuring that our medical devices comply with all applicable regulations and standards.Key ResponsibilitiesInvestigate complaints and evaluate events to determine if they...
-
Quality Compliance Specialist
hace 5 días
Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completo**Job Summary**We are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a Quality Compliance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.**Key Responsibilities:**Investigate complaints that include...
-
Quality Compliance Specialist
hace 5 días
Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completo**Job Summary**We are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a Quality Compliance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and regulatory compliance.**Key Responsibilities:**Investigate complaints that include...
-
Quality Compliance Specialist
hace 4 semanas
Valencia, Valencia, España Edwards Lifesciences A tiempo completoRole Overview: As a Quality Compliance Specialist, you will ensure adherence to relevant medical device regulations and standards, including ISO13485, within the designated complaint handling unit. Your expertise will be vital in evaluating events for their reportability to regulatory authorities.Key Responsibilities:• Conduct thorough investigations of...
-
Quality Compliance Specialist
hace 2 días
Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completoAbout the RoleWe are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesInvestigate complaints and evaluate events to determine if they qualify as a...
-
Quality Compliance Specialist
hace 2 días
Valencia, Valencia, España Edwards Lifesciences Gruppe A tiempo completoAbout the RoleWe are seeking a highly skilled Quality Compliance Specialist to join our team at Edwards Lifesciences Gruppe. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesInvestigate complaints and evaluate events to determine if they qualify as a...
-
Retail Compliance Specialist
hace 5 días
Valencia, Valencia, España G-STAR A tiempo completoAbout the RoleG-Star is seeking a highly skilled Retail Compliance Specialist to join our team in Valencia. As a key member of our Retail Operations team, you will be responsible for ensuring compliance with all relevant legislations, regulations, and industry standards.Key ResponsibilitiesCompliance Management: Develop, implement, and oversee all retail...
-
Medical Device Quality Engineer
hace 1 semana
Valencia, Valencia, España Celestica A tiempo completoAbout the RoleCelestica is seeking a highly skilled Quality Assurance Specialist to join our Healthcare Quality department in Valencia, Spain. As a key member of our team, you will be responsible for ensuring the quality of our medical devices and managing interactions with customers and technical issues related to our products.Key ResponsibilitiesQuality...
-
Medical Device Quality Engineer
hace 6 días
Valencia, Valencia, España Celestica A tiempo completoAbout the RoleCelestica is seeking a highly skilled Quality Assurance Specialist to join our Healthcare Quality department in Valencia, Spain. As a key member of our team, you will be responsible for ensuring the quality of our medical devices and managing interactions with customers and technical issues related to our products.Key ResponsibilitiesQuality...
-
Regulatory Compliance Expert
hace 4 semanas
Valencia, Valencia, España Edwards Lifesciences A tiempo completoRole Overview: As a key player in our Quality Compliance team, you will ensure adherence to medical device regulations, including ISO13485, for our designated complaint handling unit. Your expertise will be crucial in evaluating events for reportability to relevant regulatory authorities.Your Impact:• Conduct thorough investigations of complaints involving...
-
Retail Compliance Specialist
hace 7 días
Valencia, Valencia, España G-STAR RAW A tiempo completoAbout the RoleWe are seeking a highly skilled and experienced Retail Compliance Specialist to join our team at G-STAR RAW. As a key member of our Retail Operations team, you will be responsible for ensuring that our retail operations comply with all relevant laws, regulations, and industry standards.Key ResponsibilitiesDevelop and implement compliance...
-
Retail Compliance Specialist
hace 7 días
Valencia, Valencia, España G-STAR RAW A tiempo completoAbout the RoleWe are seeking a highly skilled and experienced Retail Compliance Specialist to join our team at G-STAR RAW. As a key member of our Retail Operations team, you will be responsible for ensuring that our retail operations comply with all relevant laws, regulations, and industry standards.Key ResponsibilitiesDevelop and implement compliance...
-
RPA Specialist
hace 7 días
Valencia, Valencia, España Vitrolife Group A tiempo completoJob SummaryVitrolife Group is a global leader in medical devices and genetic services. We are seeking a highly skilled Diagnosis Specialist to join our team.Key ResponsibilitiesPerform high-complexity tests and report results in a timely and accurate manner.Identify and correct problems that may affect test performance or reporting.Document all...
-
RPA Specialist
hace 7 días
Valencia, Valencia, España Vitrolife Group A tiempo completoJob SummaryVitrolife Group is a global leader in medical devices and genetic services. We are seeking a highly skilled Diagnosis Specialist to join our team.Key ResponsibilitiesPerform high-complexity tests and report results in a timely and accurate manner.Identify and correct problems that may affect test performance or reporting.Document all...
-
Regulatory Compliance Expert
hace 1 semana
Valencia, Valencia, España Celestica A tiempo completoAbout the RoleCelestica is seeking a highly skilled Quality Assurance Specialist to join our Healthcare Quality department in Valencia, Spain. As a key member of our team, you will be responsible for ensuring the quality of our medical devices and managing interactions with customers and technical issues related to our products.Key ResponsibilitiesQuality...
