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Jack Caffrey
Life Science

01 507 9279
[email protected]
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Details

Assoc MDR/Vigilance Specialist


Reference:JSC0008729 Location: Galway
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Regulatory Affairs

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Responsibilities may include the following and other duties may be assigned.


  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
  • Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
SPECIALIST CAREER STREAM:
  • Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
  • May act as a mentor to colleagues or may direct the work of other lower level professionals.
  • The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS Autonomy:
  • Entry-level individual contributor on a project or work team. Works with close supervision. Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.

Innovation and Complexity:
  • Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.

Communication and Influence:
  • Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm and convey information.
Requirements:
  • Qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline.
  • 2 years relevant experience
  • Dynamic team player, attention to detail, goal-orientated, good communicator and problem solving skill-sets.
  • Medical device experience desirable
  • 100% desk based


Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role. Contact Jack Caffrey at [email protected] for more details