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Search Results for Medical Device
Job Title. Location Salary Actions

Senior Regulatroy Affairs Specialsit

Senior Regulatory Specialist Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy. Role/Responsibilities Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support...

Location: Galway,
Senior Regulatroy Affairs Specialsit
Galway Not Disclosed

Quality Systems Manager

Role: Quality Systems Manager Location: Newenham Court, Malahide Team: 8 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Competitive salary, 10-15% bonus, pension and full family healthcare Day to day: Manage and maintain the Quality Management System for GDD - ensuring compliance is maintained against ISO 13485: 2016, 21 CFR 820 (and relevant territorial Quality System requirements as they arise within the organization); Monitor the performance of the QMS and implement necessary remediation activities to ensure steady state ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager
EU Not Disclosed

Quality Engineer

Role: Quality Engineer Location: Athone, Westmeath Benefits: Excellent salary, pension healthcare and yearly bonus Contract length: 24 months based on site Company: Multinational Medical Device company focussing on the development of cutting-edge medical devices in Airway Management but also for other life enhancing applications. Responsibilities: - Develops, modifies, applies, and maintains quality standards and protocols for processing materials into...

Location: Midlands, Roscommon, Westmeath,
Quality Engineer
Midlands Not Disclosed

Neurovascular Research Manager

Job title: Neurovascular Disease Research Engineer Location: Ballybrit, Galway Benefits: Hybrid working model, competitive salary, 13% yearly bonus, pension and Healthcare. Company: My client is an emerging leader in Neurovascular care in the Medical Device industry. Located in a European hub for the Medical Device industry my client works closely with physicians from around the world to develop devices used in the endovascular treatment of strokes. Role: The NVD Research Manager will be part of the Neuro Thromboembolic Initiative (NTI%2...

Location: Galway, Galway City,
Neurovascular Research Manager
Galway Not Disclosed

Medical Device Director

Our client a Medical Devcie notifeid body are currently seeking Director of Medical Devices to join their team. The Director of Medical Devices will have overall leadership repsonsibility for European and US Medical Division and provide leadership and strategic guidance. Role can be based in Dublin or Galway and can provide hybrid Roles/Responsibilities Responsible for European and US Medical Device Division Manage resources for Global Medical Device division Responsible for department KPIs and all certifications filed Oversee global audit team planning Mem...

Location: Republic of Ireland,
Medical Device Director
Republic of Ireland Not Disclosed

Regulatory Affairs Director

Regulatory Affairs Director Our client a global healthcare company is currently seeking a Technical Device Regulatory Affairs Director to join their team. Director will be responsible for all aspects of Regulatory Affairs for their portfolio of devices Role/Responsibilities: Accountable to define device regulatory requirements and regulatory strategy to development teams to ensure readiness for medical device (MD) and combination product (CP) approvals. Critically review, approve, and lead strategy for global regulatory submissions for device compo...

Location: Dublin,
Regulatory Affairs Director
Dublin Not Disclosed

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...

Location: Cork,
Regulatory Affairs Specialist
Cork Not Disclosed

Senior Regulatory Affairs Specialist

Our client a medical device start up are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approvals. This position can be fully remote. Role/Responsibilities Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy. Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant...

Location: Dublin,
Senior Regulatory Affairs Specialist
Dublin Not Disclosed

Senior Regulatory Affairs

Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System Role/Responsibilities Manage the regulatory and vigilance process. Prepare regulatory submissions for required markets coordinating input from other stakeholders, tr...

Location: Galway,
Senior Regulatory Affairs
Galway Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...

Location: Westmeath,
Senior Regulatory Affairs Specialist
Westmeath Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a...

Location: Dublin,
Senior Regulatory Affairs Specialist
Dublin Not Disclosed