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Search Results
Job Title. Location Salary Actions

Pharmacovigilance Regulatory Affairs Advisor Fully Remote

Pharmacovigilance Regulatory Affairs Advisor-Fully remote Our client, a regulatory consultancy organisation are currently recruiting for a Pharmacovigilance Regulatory Affairs Advisor to join their team on permanent basis. This role is 100% home based. Responsibilities Creation & review, with strong emphasis on critical evaluation, of all clinical reports, efficacy & safety summary reports while working collaboratively with clients. Preparation of Risk Management Plans (RMP's), Signal Detection Reports, PSUR's with assessment of ...

Location: Republic of Ireland,
Pharmacovigilance Regulatory Affairs Advisor Fully Remote
Republic of Ireland Not Disclosed

Senior Clinical Data Management Associate

Our client is a Global Biopharma who are establishing a Paediatric Centre of Excellence in Dublin that will be responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. The Clinical Operations team in Dublin is a pivotal function within this Centre of Excellence. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory gui...

Location: Dublin,
Senior Clinical Data Management Associate
Dublin 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 strategy develop...

Location: Cork,
CMC Development Regulatory Associate
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

Clinical Development Director (Oncology)

Our client is a global Biopharma who are establishing a Clinical Trials Centre of Excellence in Dublin, Ireland. They are seeking a qualified Medical doctor (essential), preferably with Oncology clinical trial experience, in the area of Haematology or a related therapeutic area. The successful person shall lead multiple components of clinical trial programs in paediatric oncology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you will be accountable for various aspects of ongoing clinical trial progra...

Location: Dublin,
Clinical Development Director (Oncology)
Dublin Not Disclosed

Senior Associate (Clinical Data Management)

Our client is a Global Biopharma organisation who have established a Clinical Trials Centre of Excellence in Dublin, responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. The Clinical Operations team are seeking a Senior Clinical Data Management Associate who will work collaboratively with internal and external colleagues and vendors to support our client’s business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications...

Location: Dublin,
Senior Associate (Clinical Data Management)
Dublin Not Disclosed

Director of Regulatory Affairs

Our client a global medical device companywho have established a European Centre of Excellence in Ireland are currently seeking a Director of Regulatory Affairs to join their team. The Director of Reg Affairs will support worldwide regulatory submissions and audits outside of USA. The Director of Regulatory Affairs will report to VP of International Operations and will be a dynamic, detail-oriented, self-directed contributor and will spot opportunities to develop and optimize regulatory strategy while managing multiple projects and priorities. The Director of &nbsp...

Location: Galway,
Director of Regulatory Affairs
Galway Not Disclosed

Clinical Development Director (Oncology)

Our client is a global Biopharma who are establishing a Clinical Trials Centre of Excellence in Dublin, Ireland. They are seeking a qualified Medical doctor (essential), preferably with Oncology clinical trial experience, in the area of Haematology or a related therapeutic area. The successful person shall lead multiple components of clinical trial programs in paediatric oncology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you will be accountable for various aspects of ongoing clinical trial progra...

Location: Dublin,
Clinical Development Director (Oncology)
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 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

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

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

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

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

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