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Search Results for Life Science
Job Title. Location Salary Actions

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

Regulatory Affairs Project Lead

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 • Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies. • Provides guidance to project team members regarding regulatory compliance issues. • Oversees the preparation and maintenance of regulatory submissions and files. &bu...

Location: Cork,
Regulatory Affairs Project Lead
Cork Not Disclosed

Senior Quality and Regulatory Manager

Senior Quality & Regulatory Manager Our client a growing Irish Med Tech company who have developed a technology that changes peoples lives currently seeks a Senior Quality and Regulatory Manager to join their team. The Senior Quality and Regulatory Manager will be required to lead the company wide Quality Management system ensuring they meet design specifications and standards for products and services. The role also has responsibility for regulatory clearance and compliance in target and existing markets, as well as providing technical support and guid...

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

Programme Manager MDR

Our client a Global Healthcare company is currently seeking a Programme Manager to join their team. The Programme Manager will prepare execution strategies and project plans for the implementation of the MDR within the Business Unit, coordinate the alignment and execution of all activities related building the new Technical Documentation and obtaining CE marking in compliance with EU MDR.With expertise in Programme Management, this individual will proactively coordinate cross-functional deliverables from R&D, Regulatory, Medical Affairs, Quality, Operations%2...

Location: Dublin,
Programme Manager MDR
Dublin Not Disclosed

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Pr...

Location: Dublin,
Director of Regulatory Affairs
Dublin 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

Regulatory Delivery Excellence Manager

Regulatory Delivery Excellence Manager Our client, a Cork based pharmaceutical organisation are currently recruiting for a Regulatory Delivery Excellence Manager to join their team on a permanent basis. As Regulatory Delivery Excellence Manager you will be responsible for the recruitment, retention and resource assignment of the regulatory associates managing submissions in the Global Regulatory Affairs organization. You will provide leadership, direction, as well as technical / process expertise to the regulatory associates responsible for the regulatory submission management p...

Location: Cork,
Regulatory Delivery Excellence Manager
Cork Not Disclosed

Quality Engineer-Operations

Quality Engineer – Operations Our client a high potential and fast growing medical device start up currently seeks a Quality Engineer to join their team. The Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks supporting the Operations function. Role/Responsibilities: Liaise with technical operations function to support the inspection and manufacturing activities at the OEM facility to ensure compliant product is consistently delivered. Develop and implement inspection proce...

Location: Galway,
Quality Engineer-Operations
Galway Not Disclosed

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Pr...

Location: Dublin,
Director of Regulatory Affairs
Dublin Not Disclosed

CMC Regulatory Specialist

CMC Regulatory Specialist required for a contract role with a Cork based Pharmaceutical client. Role Summary: Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them rega...

Location: Cork,
CMC Regulatory Specialist
Cork Not Disclosed

Director Regulatory Affairs

Director Regulatory Affairs Our client, a growing biotech organisation are currently recruiting for a Director of Regulatory Affairs to join their organisation on a permanent basis. As Director of Regulatory Affairs will be responsible for the coordination and the day-to-day support of the regulatory affairs strategy and operational activities of the organisation. You will provide support to both CMC, non-clinical, and clinical development. Responsibilities Coordinate input from external regulatory affairs consultants, identify and close knowledge gaps Provide regulatory...

Location: Dublin, Republic of Ireland,
Director Regulatory Affairs
Dublin Not Disclosed

Director of Regulatory Affairs

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device. Role/Responsibilities Provides Regulatory leadership for the development and clinical teams. Develops innovative and effective worldwide Regulatory strategies for the product roadmap. Provi...

Location: Dublin,
Director of Regulatory Affairs
Dublin Not Disclosed

CMC Regulatory Specialist

CMC Regulatory Specialist Our client, a global pharma company are currently recruiting for a CMC Regulatory Specialist to join their team on a permanent basis.As CMC Regulatory Specialist you will support new product approvals, existing product renewals, and post-approval changes for global registrations, through document distribution and internal database maintenance. You will closely with regulatory product representatives providing guidance to them regarding the regulatory documentation, reporting requirements and registration processes in global markets. ...

Location: Cork,
CMC Regulatory Specialist
Cork Not Disclosed

CMC Regulatory Associate

CMC Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission rel...

Location: Cork,
CMC Regulatory Associate
Cork Not Disclosed

CMC-Development Regulatory Associate

CMC – Development Regulatory Associate Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding stra...

Location: Cork,
CMC-Development Regulatory Associate
Cork 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 Quality Assurance Specialist

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 •The Quality Assurance (QA) Specialist is a senior and active role within the broader QA function. •The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. •QA specialists will b...

Location: Dublin,
Senior Quality Assurance Specialist
Dublin Not Disclosed

Clinical Regulatory Associate

Clinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permane

Location: Cork,
Clinical Regulatory Associate
Cork Not Disclosed

Clinical Publisher Associate

Clinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide...

Location: Cork,
Clinical Publisher Associate
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

Senior Tech Transfer Lead

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 This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. The candidate will establish themselves in a product lead role where the majority of input provided will be leading of process performance qual...

Location: Dublin,
Senior Tech Transfer Lead
Dublin Not Disclosed

Senior R&D Engineer

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 Seeking an experienced engineer to focus on all stages of the product development process from concept generation through to commercializing of cutting-edge structural heart devices. This is an exciting opportunity to get involved in the rapidly growing world of Structural Heart. The role includes the fol...

Location: Galway,
Senior R&D Engineer
Galway Not Disclosed

Senior Manufacturing Engineer

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 At our Manufacturing Engineering Department, we focus on providing Stable, Flexible and Cost Effective Manufacturing processes that produce the highest quality products through innovative engineering services and solutions. Manufacturing Engineers are directly involved in maintaining and continuously ...

Location: Galway,
Senior Manufacturing Engineer
Galway Not Disclosed