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Search Results for Medical Device
Job Title. Location Salary Actions

Assoc MDR/Vigilance Specialist

We’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance. Responsibilities Responsible for the co-ordination of complaint ha...

Location: Galway,
Assoc MDR/Vigilance Specialist
Galway Not Disclosed

Snr Associate QA

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 24/7, 12hr shift role - Eye Test Required for this position - Inspection Role. Primarily dealing with manufacturing activities, troubleshooting issues in production. Quality contact on deviations. Batch record review for manufacturing. SOPs. filling, setups and work on lines, inspection, triage issues relati...

Location: Dublin,
Snr Associate QA
Dublin Not Disclosed

Project Manager - Vigilance

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties • Develop a coordinated plan to advance strategic projects in alignment with internal and external stakeholders. • Ensure development and attainment of project objectives, along with defining success measures. • Implement a governance structure and actively engage and communicate with executiv...

Location: Cork,
Project Manager - Vigilance
Cork 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 Quality and Regulatory Engineer

Senior Quality and Regulatory Engineer-Start Up Our client a well-funded start up with a management team with a proven track record in start up are currently seeking a Senior Sustaining QARA Engineer to join our team and work with us on expanding our innovative product portfolio and market roll-out. The position of Senior Quality and Regulatory Engineer will be responsible to provide technical and administrative quality and regulatory support to ensure maintenance of the Quality System Compliance, maintenance of existing products and timely introduction of new produ...

Location: Galway,
Senior Quality and Regulatory Engineer
Galway Not Disclosed

MDR/Vigilance Specialist

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow up on adverse reports, participation in the resolution of any legal liability and in...

Location: Galway,
MDR/Vigilance Specialist
Galway Not Disclosed

Regulatory Affairs Specialist

Life Science Recruitment is hiring for a Regulatory Affairs Specialist to join our clients expanding Life Sciences division. This is a hybrid role, the successful candidates will be responsible for managing Quality Systems, Regulatory Compliance, and support Quality Engineering activities for our clients and work for a variety of products and technologies to ensure compliance with medical device standards and regulations, including: 21 CFR Part 820, ISO 13485, MDD, AIMD, MDR and CMDCAS. Responsibilities: Be a Regulatory Affairs subject ...

Location: Republic of Ireland,
Regulatory Affairs Specialist
Republic of Ireland 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 EHS Specialist

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for

Location: Cork,
Senior EHS Specialist
Cork 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