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

Regulatory Affairs & Communications Specialist

The Regulatory Affairs Specialist - Regulatory Communications serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS, PMCF, CER) and associated correspondence to applicable Regulatory bodies. Reporting to: Senior Regulatory Affairs Specialist, you will: • Assess complaints from global distribution centres for adequate information to det...

Location: Limerick,
Regulatory Affairs & Communications Specialist
Limerick Not Disclosed

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

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
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Manager Westmeath Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Regulatory Affairs Specialist Cork Not Disclosed

Regulatory Affairs Officer Career Profile

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.