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Job Title. Location Salary Actions

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

Medical Advisor (Medical Devices)

Our client is a leading Medical Device organisation based in Limerick. They are seeking a Medical Doctor with strong interpersonal skills to collaborate across business functions and business units, applying clinical knowledge and expertise to support device benefit and risk assessment, regulatory submissions, product development, internal and external training, market research, and sales and marketing efforts. Role/Responsibilities: • Build and maintain a working knowledge of product lines, both new and existing products, and the clinical procedures in whic...

Location: Limerick,
Medical Advisor (Medical Devices)
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

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 & 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

Consultant

Life Science Recruitment is a specialist recruitment agency with a focus on the recruitment and selection of professionals for the pharmaceutical, biotechnology

Location: Cork,
Consultant
Cork Not Disclosed

Mechanical Design Engineer

Mechanical Design Engineer required to focus on the development of cutting edge medical devices in the Cardiac and Vascular space. Engineers are directly involved in the development of innovative products for use in medical procedures. Principal R&D Engineers are directly involved in all stages of the product development process from concept generation through to commercialization of cutting edge devices such as structural heart devices. Responsibilities: Support basic clinical need through opportunity assessment and device concept to prototype. You will participate in...

Location: Galway,
Mechanical Design Engineer
Galway Not Disclosed

QA Specialist (QC)

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.Provide support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. GENERAL SCOPE OF RESPONSIBILIT...

Location: Cork,
QA Specialist (QC)
Cork 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
Other Medical Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Associate Westmeath Not Disclosed
Medical Advisor (Medical Devices) Limerick Not Disclosed