Senior Quality & Regulatory Manager required by successful medical devices scale-up company in Galway. You will lead the company-wide Quality Management system ensuring design specifications and standards for products and services are met. You will also be responsible for regulatory clearance and compliance in existing markets and target markets, as well as providing technical support and guidance for new product introductions, labelling and marketing claims. To be considered you should have proven ability to lead the Quality Assurance agenda across the company; have substantial experience of regulatory processes for FDA, UK, and EU product clearance; experience of quality management including design control and excellent people and team management skills

Requirements: 

  • Third level Degree in Quality / Regulatory / Medical Device Engineering

  • Post graduate qualification in Quality Assurance would be ideal

  • 10+ years’ experience in quality / regulatory roles in the medical devices sector

  • Experience managing quality and regulatory teams

  • Significant regulatory affairs experience including experience of international regulatory processes including FDA, EU, and UK for Medical Devices

  • In depth knowledge of maintaining a certified Quality Management System

  • Knowledge of product certification testing requirements for Medical Devices
    Knowledge and application of Quality tools and Methodologies including lean six sigma etc.

  • Knowledge of IEC 62304 (medical device software lifecycle process)

  • Trained QMS Internal Auditor

  • High level of attention to detail

  • Proven leadership skills

  • Excellent Verbal and written communication skills

  • Results orientated and a self-starter with the ability to work on own initiative

  • Pragmatic and comfortable dealing with ambiguity

  • Knowledge of and commitment to continuous improvement and problem solving

  • Advanced Microsoft Office and reporting tool skills

  • Strong project management skills

Key Responsibilities:

  • Effectively lead and manage the QA/RA team
  • Proactive management of the processes to ensure product and service quality
  • Act as Management Representative for the Quality Management System
  • Reporting to top management on the effectiveness of the quality management system and any need for improvement
  • Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
  • Responsible for FDA facility inspections, notified body audits and other audits and inspections as required
  • Establish infrastructure to assure quality and work with relevant teams to ensure performance improvement
  • Ensure the effective functioning of design controls to ensure product quality
  • Represent the quality department in all NPI/NPD activities to ensure that all new products are compliant to appropriate international quality and regulatory requirements
  • Generate and maintain instructions for use and regulatory labelling for all products
  • Ensure that software and firmware is being developed in accordance with IEC 62304
  • Ensure the development and maintenance of the risk management plan in accordance with ISO 14971
  • Ensure company is kept informed of and given direction on changing regulatory and compliance requirements e.g., REACH ROHS2 etc.
  • Support the commercial team with respect to compliance with local regulatory laws and environmental regulations in market as well as advertising/clinical claims
  • Responsible for Post Marketing Surveillance for the company and reporting to appropriate regulatory bodies as required

    
emer@emtechrecruitment.ie

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