Quality & Regulatory Senior Associate

3 weeks ago

Dublin, Dublin City, Ireland Vasorum Ltd. Full time

4 days ago Be among the first 25 applicants

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Vasorum Ltd, an Irish medical device company based in Dublin, are seeking to hire a Senior Quality and Regulatory Associate to join their team. Reporting directly to the Quality and Regulatory Manager, this will be a pivotal role for the day-to-day operational execution of the Quality Management System and ensuring regulatory compliance. The ideal candidate will demonstrate excellent communication and people management skills while guiding our small team to ensure all activities remain adherent to our QMS.

This is an exciting opportunity to join a growing medical device company with an established commercial product and a novel development pipeline.

Responsibilities

QMS Operations

  • Day-to-day operation of QMS systems.
  • Coordinates / Leads continuous quality improvement.
  • Supports the Quality and Regulatory manager with regular review of the change control process, to make sure it remains effective and efficient.

Documentation

  • QMS documentation management.
  • Uploading and archiving documents.
  • Maintaining and developing the technical aspects of quality, databases, e.g. complaints, Non-conformances, CAPAs.
  • Generation and upkeep of all associated quality and regulatory files and records.

Manufacturing & R&D

  • Support maintenance of Design History Files, with the Project leaders.
  • Generate dashboards of Risk Management outputs and controls for Risk Management reports
  • Coordinate QARA aspects of medical device production

Post-Market

  • Complaint Reporting and Vigilance Coordinator.

Compliance & Audits

  • Training Coordinator for QMS.
  • Carry out internal audits against planned schedules.
  • Supports ongoing quality and regulatory compliance to relevant standards, guidance, and regulations in the EU and the US.
  • Coordinate the tracking and presentation of KPIs against quality objectives.
  • Supports facility inspections/ audits by the FDA, Notified Body, as required.

Regulatory Support

  • Coordinates for preparation of regulatory submissions.
  • Participating in the establishment and maintenance of effective procedures for quality and regulatory compliance.

Technical Skills/Experience

  • University Degree or a Post Graduate qualification, in Science or Engineering.
  • 5+ years of experience in Medical Devices or other similar regulated industry.
  • QARA experience, including in-depth knowledge of maintaininga certified QMS.
  • Extensive knowledge of ISO 13485, 21 CFR 820 and Medical Device Regulations (EU_MDR) & other key industry standards.
  • Trained QMS Internal Auditor.
  • Experience in quality assurance process implementation and improvement.
  • Significant regulatory affairs experience, including experience in international regulatory submission processes.
  • Quality mindset and drive to stay abreast of evolving regulations and proactively assess their impact on products and processes.
  • Experience in a medical device manufacturing facility.

Leadership Skills

  • Proven skills in coordinating and managing the delivery and completion of tasks in a Team environment in line with deadlines.
  • Results-oriented and a self-starter with the ability to work on own initiative.
  • High level of attention to detail.
  • Knowledge of and commitment to continuous improvement.
  • Technical Report writing skills.
  • Advanced Microsoft Office and reporting tool skills. Use of Digital Technologies for the medical device industry, including regulatory submission processes.

Complimentary Skills

  • Knowledge of product certification testing requirements for Medical Devices.
  • Knowledge and application of Quality tools and methodologies, including Lean Six Sigma, TQM etc.
Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionLegal
  • IndustriesMedical Equipment Manufacturing

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