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Medical Devices Company jobs in Spiddal, County Galway

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    • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse…
    • View all CPL jobs - County Galway jobs - Associate jobs in County Galway
    • Salary Search: Associate MDR/Vigilance Specialist salaries in County Galway
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    • Follow quality, safety, and documentation requirements to ensure products meet regulatory and company standards.
    • Role Type: Full-Time, Permanent, On-Site.
    • Experience in medical device assembly or similar is preferable not essential.
    • Perform a variety of medical assembly and processing tasks as a production team…
    • Proven experience in a General Manager or senior leadership role within medical devices, engineering or manufacturing.
    • Health Insurance: Rely on comprehensive services whenever you need it.
    • Flexible Work Models: We allow for flexible work models to ensure both professional and…
    • Experience in thermoforming, plastics or medical device packaging is an advantage.
    • The Quality Technician is the on-floor quality presence in the cleanroom,…
    • Clinical/medical background is a plus.
    • Manage ordering, tracking, and accountability for investigational devices and other trial materials.
    • We currently have a Production Packer position on Day shift.
    • 12-month Fixed Term Contract with a strong potential of a permanent contract.
    • Good working knowledge of ISO 13485, FDA requirements and medical device Quality Systems.
    • Health Insurance: Rely on comprehensive services whenever you need it.
    • Knowledge of manufacturing processes within a pharmaceutical/ medical device environment desirable but not essential.
    • Save for retirement with the company's help.
    • Ideally a minimum of 5 years engineering experience within a medical device, pharmaceutical or similarly regulated…
    • This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross-functional teams and…
    • Minimum of a Leaving Certificate and 1-2 years’ experience within a Pharmaceutical or medical device company, preferably in a compounding/ dispensing area.
    • Proven experience in GMP pharmaceutical or medical device manufacturing.
    • As Value Stream Manager – Cartridge Filling, you will support the delivery of 3-year…
    • Knowledge of manufacturing processes within a pharmaceutical/ medical device environment desirable but not essential.

Job Post Details

Associate MDR/Vigilance Specialist
CPL
·
3.4
County Galway
Temporary
Apply on company site

Job details

Pay information not provided
Temporary
County Galway

Full job description

Associate MDR/Vigilance Specialist

Responsibilities


  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports.
  • Participates in the resolution of any legal liability and ensures compliance 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.
  • Reviews and analyzes clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database.
  • Supports ADE standardization and internalization to ensure 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.
  • Delivers and/or manages assigned projects and works with stakeholders to achieve desired results.
  • May mentor colleagues or direct the work of lower-level professionals.
  • Focuses primarily on delivering and overseeing projects from design to implementation while adhering to policies and using specialized knowledge.


Requirements


  • Entry-level individual contributor with responsibility in a professional discipline or specialty.
  • Works with close supervision.
  • Delivers work of limited scope, typically on smaller and less complex projects.
  • Identifies and addresses problems that are typically not difficult or complex; makes minor changes to systems and processes.
  • Communicates primarily with internal contacts within the immediate group to gather, confirm, and convey information.
  • Focuses on self-development; no leadership or talent management responsibilities at this level.
  • Requires broad theoretical job knowledge, typically obtained through advanced education.


For a confidential discussion on this opportunity, please contact:

Morgan Danaher

Principal Consultant | Cpl Engineering & Construction

morgan.danaher@cpl.ie

087 164 7527

Alternatively, apply today with an updated CV.

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