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Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

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

Technical Device Regulatory Maanger

Our client a Global Device Development organisation focused on the design, development and commercialisation of a diverse portfolio of device technology solutions are currently seeking a Technical Device Regulatory Manager to join their team. Reporting to Director of Regulatory the Regulatory Manager will have a thorough understanding of Device Regulatory requirements and capability to lead and guide a team Role/Responsibilities : Subject Matter Expert in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory complia...

Location: Dublin,
Technical Device Regulatory Maanger 		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

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

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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
QA/RA Director -Start Up Medical Device Galway Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Senior Regulatory Affairs Specialist Dublin Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
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Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager


This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations