Medical Device Complaints Specialist

Overview Work as part of the Quality Engineering to provide an efficient service to our customers internally and externally in dealing with product complaints issues and other relevant quality assurance projects as they arise.Reporting to: Team Lead, Quality Engineering Department: Complaints Responsibilities Department: Complaints Investigation of Customer...

Cook Medical is looking for a highly motivated Medical Device Compliance Specialist to join our team. As a Medical Device Compliance Specialist, you will be responsible for ensuring that our products comply with relevant regulations and guidelines. This includes maintaining an active oversight of the quality management system (QMS) and ensuring compliance...

Job Summary:We are seeking a seasoned Medical Device Compliance Specialist to join our regulatory affairs team. As a key contributor, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in targeted markets.You will work closely with cross-functional teams to develop and implement regulatory strategies,...

Job SummaryWe are seeking a Medical Device Innovation Specialist to join our Research and Development team at Cook Medical Incorporated. This role requires strong technical and leadership skills to develop and implement innovative solutions for our medical devices.Key ResponsibilitiesDevelop and implement innovative solutions for our medical devices,...

Job Summary:We are seeking an experienced Medical Device Compliance Manager to join our regulatory team. In this role, you will be responsible for ensuring the compliance of our medical devices with global regulations.About the Role:You will develop regulatory strategies for our medical devices, ensuring compliance with global regulations.You will perform...

Key ResponsibilitiesThe Regulatory Affairs Specialist 2 plays a critical role in ensuring the company's medical devices meet regulatory requirements.This includes:Maintaining a deep understanding of global medical device regulations.Developing and implementing regulatory strategies.Communicating regulatory requirements to internal stakeholders.Ensuring...

Job SummaryWe are seeking a highly skilled Medical Device Compliance Specialist to join our team at Cook Medical. In this role, you will be responsible for ensuring regulatory compliance to the EU MDR at our office of the EU Authorised Representative.The successful candidate will serve as a communication liaison between our manufacturer and the EU regulatory...

About the RoleWe are looking for a highly motivated and experienced Regulatory Affairs Specialist 2 to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the commercialization of our medical devices in target markets.In this role, you will:Develop and implement regulatory strategies that meet the...

About This RoleThis position is responsible for developing and implementing post market surveillance (PMS) plans and reports for Cook Medical Incorporated medical devices. Additionally, the successful candidate will be involved in activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs,...

Role OverviewThe Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the EU regulatory authorities.Main Tasks:Maintain up-to-date understanding of medical device regulations, including EU MDR, EMEA, and EN ISO 13485.Work closely with global project manager EU MDR and other team members to implement EU MDR...

Job SummaryCook Medical is looking for a talented Medical Device Strategist to develop and implement regulatory strategies for our medical devices. The successful candidate will have a deep understanding of global medical device regulations and be able to communicate effectively with stakeholders.Key ResponsibilitiesDevelop and maintain an excellent...

Company OverviewCook Medical is a leading manufacturer of medical device products.

About the RoleThe Device Certification Specialist will be responsible for maintaining an excellent understanding of global medical device regulations for specific jurisdictions, including ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21 CFR Part 820.You will communicate country/region-specific regulatory requirements to internal...

OverviewAbout UsCook Medical is a leading medical device manufacturer dedicated to improving patient outcomes through innovative solutions.Job DescriptionWe are seeking an experienced Medical Device Engineer to lead and/or participate in projects focused on design modifications of devices post release to market. The primary function of this position is to...

About the JobWe are looking for a Complaints Investigator to join our Quality Engineering team at TN Ireland. As a Complaints Investigator, you will be responsible for investigating customer complaints and ensuring that all complaints are properly investigated in accordance with appropriate procedures and regulatory requirements.Key...

Join Our Team as a Senior Validation Engineer in Medical DevicesWe are currently seeking an experienced professional to fill a key role in our medical device quality assurance team. As a Senior Validation Engineer, you will play a vital part in ensuring the quality and compliance of our medical devices.Your primary responsibilities will include:VALIDATION:...

OverviewCook Medical is seeking a highly skilled Regulatory Scientist 2 to join our team. In this role, you will be responsible for the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices.In addition, you will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF),...

About UsCook Medical is a global leader in the development and manufacturing of medical devices. Our mission is to invent, manufacture, and deliver innovative solutions to improve patient outcomes.We are seeking an experienced Medical Device Development Lead to join our Research and Development team in Limerick, Ireland.

Key ResponsibilitiesMaintain an excellent understanding of global medical device regulations for specific jurisdictions, including ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSP 21 CFR Part 820.Communicate country/region-specific regulatory requirements to internal stakeholders.Develop and maintain thorough knowledge of products...

Cook Medical's Regulatory Affairs department is seeking a talented Medical Device Regulatory Expert to support the development and implementation of regulatory strategies for our medical devices.The successful candidate will have a deep understanding of medical device regulations, including ISO 13485, MDD 93/42/EEC, and FDA QSP 21CFR Part 820.This role...