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Search Results for
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

Our client a medical device early stage company wishes to add a Regulatory Affairs Specialist to our team. The successful candidate will work with the Design, Quality and Regulatory teams to support all regulatory functions for both existing and new products. Role/Responsibilities • Contribute to the regulatory strategy plans for new products, including required Regulatory Agency approvals. • Provide regulatory input into labelling, test strategies for new product development, risk analysis, clinical, preclinical and marketing issues. • Planning,...

Location: Cork,
Regulatory Affairs Specialist
Cork Not Disclosed

Regulatory Affairs Manager

Regulatory Affairs Manager Our client a medical devcie multinational currently seeks a Reg Affairs Manager to join their team. Reporting to Senior Director QA/RA the Reg Affairs manager will support the Strategic Manufacturing group to prepare global submission and registration documents in support product transfer activities; complete risk management activities, transfer and maintain technical files/design dossiers for the transfer products. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain worldwide Regul...

Location: Westmeath,
Regulatory Affairs Manager
Westmeath Not Disclosed

Regulatory Affairs Officer

Regulatory Affairs Officer This company are exclusively sourcing a Regulatory Affairs Officer based in Limerick. The ideal candidate will have a degree in molecular science with the ability and confidence to undertake all associated responsibilities. This role will also involve R&D Liaison with R&D teams. Roles & Responsibilities Coordination of post market surveillance/vigilance reporting for CE-IVD marked products. Coordination of risk management activities and documentation for CE-IVD marked products. Communication of specific regulatory requir...

Location: Limerick,
Regulatory Affairs Officer
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 & Quality Manager

Regulatory Affairs & Quality Manager Our client a cardiovascular medical device start-up looking to hire a Quality and Regulatory Affairs manager. The succ

Location: Dublin,
Regulatory Affairs & Quality Manager
Dublin 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

Head of Quality & Regulatory Affairs

Head of Quality & Regulatory Affairs Our client a multinational healthcare company currently seeks Head of Quality and Regulatory Affairs. Reporting to Ge

Location: Dublin,
Head of Quality & Regulatory Affairs
Dublin Not Disclosed