Job Title.	Location	Salary	Actions
Senior Regulatory Affairs Specialist Senior Regulatory Affairs Specialist Responsibilities · Liaison with R & D to support device development and approval planning and execution. · Provide guidance to the relevant functions on FDA requirements for both in vivo and in vitro test programmes designed to support submissions. · Lead design assurance activities for all projects to ensure successful transfer of the design to manufacturing. · Support Design History File completion and documentation review. · Generation of IDE and other submissions as required for prod... Location: Galway, Senior Regulatory Affairs Specialist	Galway	Not Disclosed
Regulatory Affairs Associate Regulatory Affairs Associate Our client is looking for a regulatory affairs associate who will deal with the compliance and approval of products. This person will also be responsible for determining and supporting regulatory activities. Responsibilities • Use technical solutions for problem solving • Improve quality of projects • Use strong writing skills to clearly define and describe technical information • Analyse customer complaints • Identify trends and corrective actions • Review and assess of change control activities for po... Location: Westmeath, Regulatory Affairs Associate	Westmeath	Not Disclosed

Job Title	Location	Salary	Actions
Director of Regulatory Affairs	Limerick	Not Disclosed
Regulatory Affairs & Quality Manager	Dublin	Not Disclosed
Quality Assurance and Regulatory Affairs Manager	Dublin North	Not Disclosed
Quality Assurance and Regulatory Affairs Manager	Dublin North	Not Disclosed

Regulatory Affairs Officer

The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer

• Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
• Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
• Preparation of dossiers to obtain CE marking for medical devices.
• Ensuring Labelling complies with appropriate legislation.
• Ensure approved regulatory requirements are enforced in-house.
• Participate in the development of electronic submission of dossiers.
• Provide support to R&D projects; including new product introductions, changes to existing products and processes.
• Liaise with suppliers, clients, development partners and regulatory bodies.
• Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
• Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.