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Search Results for Regulatory Affairs Specialist
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

Quality Assurance and Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager Our client, one of the largest biomedical innovator based in Dublin is looking to recruit QA/RA Manager wh

Location: Dublin North,
Quality Assurance and Regulatory Affairs Manager 		Dublin North Not Disclosed

Risk Manager

Risk Manager - Medical Device-User Interface Life Science Recruitment has been exclusively engaged to source a Risk Manager for our client in Dublin. The ideal candidate will demonstrate subject matter expertise in the application of FDA and EU regulations and international standards related to design control, user interface and risk management. The individual must also possess an interest in maintaining an awareness of the device development landscape and have the technical drive and confidence to represent our client from an external perspective where necessary. The Risk Manager will...

Location: Dublin,
Risk Manager 		Dublin Not Disclosed

Regulatory Affairs Specialist

REGULATORY AFFAIRS SPECIALIST Our client a Galway based medical device start up company is recruiting an RA Specialist. The successful candidate will work on

Location: Galway,
Regulatory Affairs Specialist 		Galway Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs & Quality Manager Dublin Not Disclosed
Regulatory Affairs & Quality Manager Dublin Not Disclosed
Quality Management Systems Specialist Dublin Not Disclosed
Quality Management Systems Specialist Dublin Not Disclosed
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Regulatory Affairs Specialist Career Profile

Regulatory Affairs Specialist

There are Regulatory Affairs (RA) opportunities available in a variety of industries: Pharmaceutical / Biotech / Agrochemical / Clinical Research Organisations (CRO's). There also exist roles in Consultancy organisations, companies which service small and large Clients in the above industries, on various projects. These can often be interesting and varied roles for the experienced RA professional.

Salary Scale:


  • Regulatory Affairs Assistant - €25,000 - €28,000
  • Regulatory Affairs Officer - €32,000 - €39,000
  • Regulatory Affairs Specialist - €40,000 - €55,000
  • Regulatory Affairs Manager - €60,000 - €80,000
  • Regulatory Affairs Director - €85,000 +

Role Responsibilities:

  • Life cycle management and Maintenance of regulatory filings including annual reports and supplements to US FDA.
  • Preparation of registration submissions, in CTD (Clinical Trial Dossier) format, for pharmaceutical products for approval by the US FDA, European Regulatory Authorities and worldwide, as required.
  • Monitoring the progress of registration submissions, responding to queries and ensuring that registration approvals are granted without undue delays.
  • Regulatory Compliance, for change control activities monitoring the impact of changes in regulatory submissions.
  • Monitoring adverse events for submissions, preparation and review and generation of supporting documents for potential field alerts and recalls.
  • Maintenance of approvals, including the preparation of annual reports for US products.
  • Assess and review documentation to ensure compliance with product licences.
  • Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
  • Actively participate in project teams, as required.

Industry Experience:

  • Minimum of 3 years regulatory experience in the pharmaceutical industry.
  • Knowledge of the current regulatory requirements, particularly US and EU.
  • Experience in writing and submitting regulatory documentation.