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

Regulatory Affairs Specialist

This job requires the person to work within the current regulatory environment and frameworks for all relevant markets. You will support marketing the products and ensure they are in conjunction with the commercial requirements. Duties/Responsibilities: • Define regulatory strategy for individual devices within the Product Development Process. • As appropriate, manage Submissions and Significant Changes and Notified Body interactions. • Assist with the preparation of egulatory filings and subsequent FDA correspondence on submissions. • Manage R...

Location: Galway,
Regulatory Affairs Specialist
Galway Not Disclosed

Senior Regulatory Affairs Specialist

Our client is a leading Pharmaceutical organisation based in the West of Ireland. The Senior Regulatory Affairs Specialist will be a member of the Research and Development, Regulatory Science group in a well-established team. The role will be very diverse – always something new to learn. Very interesting products -very dynamic. This role will give experience of dealing with health authorities worldwide & working on maintenance projects as well as new projects. It will also involve the person taking leadership on projects under supervisor’s guidance. Full traini...

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

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.