Associate MDR/Vigilance Specialist
· Location: Galway
· Role type: Hybrid
· Job Type: Contract (12 months), Full-time.
· Salary: €37,200 - €46,500
Our client Medtronic are a well-known and highly regarded employer in the Galway region. Positions at this employer are highly sought after with excellent conditions, career prospects, permanency post contract and flexible working conditions in place wherever possible. 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.
Key skills and experience:
· Qualified person to bachelor's degree (Level 8 NFQ) in Engineering/ Science or related discipline.
· Candidates with a legal or clinical qualification (e.g., registered nurse or experience in physiological or clinical measurement science) will also be considered. 1-2 years relevant experience in a medical devices or related environment.
· Dynamic team player who can work effectively and proactively on cross functional teams.
· Ability to think critically and make sound decisions.
· Must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
· Good communicator and fluent in English, both in writing and speaking.
· 100% desk based.
· Medical device experience desirable
Simply Apply Now or contact [email protected] for further information.
