Hot Regulatory Affairs Jobs

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,

Quality Management Systems Specialist

Our client is a the leading medical device distributor across Ireland and the U.K. They are seeking a QMS Specialist with a minimum of 1 years previous experience. The QMS Specialist will report to the QCRA Manager across the Healthcare Group to support their Quality Management System requirements. This role will require occasional travel between offices in Dublin, Belfast and Great Britain. A full, clean drivers licence is required. This role requires a person who is capable of developing strong internal customer relationships between their various sites. Role/Responsibil...

Location: Dublin,

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,

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,

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,

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,

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,