Head of Quality Assurance & Regulatory Affairs

Recruiter
Osborne
Employment Type
Permanent
Salary
€100,000 per annum
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Our client, a medical device manufacturer, is seeking a Head of Quality Assurance & Regulatory Affairs to join their growing team in Dublin, reporting to the Managing Director.

Responsibilities

  • Responsible for the implementation and maintenance of clauses and systems in compliance to ENISO including the applicable elements regional requirements, (21CFR820, HSA, MDD, MDR, MDSAP etc.)
  • Maintenance and compliance of ENISO and other regulatory standards when appropriate
  • Leadership of Quality Department to ensure effectiveness in the delivery of site and departmental goals, including allocation of work and project management.
  • Provide management and Leadership to the organization in the development and implementation of regulatory strategies to gain product approvals.
  • Responsible for keeping management informed about regulatory status of products and significant regulatory issues
  • Act as management Representative for regulatory authorities providing counsel training and interpretation of regulatory standards and compliance to all personnel within the organization.
  • Responsible for the preparation and conduct of all inspections / audits by any regulatory authority and customer.
  • Oversee preparation and filing of all regulatory documents with relevant regulatory bodies.
  • Develop and maintain external relationships with key opinion leaders and regulatory officials
  • Direct the development of systems, practices and processes to ensure efficient / effective ongoing review of product design and / or manufacturing and post market surveillance.
  • Provide Leadership and direction for significant regulatory changes that may impact compliance status or represent significant business risk.
  • Management of document and design change control process to ensure all changes are handled within the requirements of company protocol.
  • Lead training and capability Development, to assure focus on problem prevention as well as detection.
  • Working with existing and developing new reporting methodologies for Key Performance Indicators across the organisation
  • Responsible for management review for the site to ensure continuous improvement of Quality Management Systems and compliance with regulatory affairs
  • Coordinate the Risk Management program, identifying the true critical to quality procedures for each product, quarterly updates to our risk management files.
  • Conduct product training, to build understanding of quality requirements in all levels of the organization through training and coaching activities.
  • Execute internal audit process and lead the organization during all third-party audits, notified body and regional authority.
  • Execution of assigned projects (design and otherwise) within cost and schedule requirements including the company initiatives lean, safety and cost reduction.
  • The ongoing drive to improve quality performance by use of CAPA, using applicable root cause analysis methodology, with a specific focus on reduction of technical support issues and customer complaint reduction.
  • Work with operations and other stake holders within the group to develop best practices in all aspects of Quality Management.
  • Manage all identified training and development activities within the organisation
  • Be available to travel both nationally and internationally as required conducting audits and providing support to suppliers and other companies associated with the group.

Essential Requirements:

  • A degree in a science related area, Chemistry/Microbiology/Quality Management/Engineering/Technical discipline or demonstrated equivalent experience
  • Knowledge of global regulatory guidelines and best practice
  • Minimum of 10 years progressive experience in Regulatory Affairs and Quality Assurance
  • Technical knowledge and experience with European and US regulations
  • Proven expertise in the design and implementation of quality processes in a world class medical device manufacturing organisation
  • Track record of success and a broad understanding of cotemporary quality practices for medical device and combination product platforms
  • Relevant experience applying Quality Risk management for device product development and manufacturing
  • Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies 
  • Proficient in pertinent software, such as Microsoft Office suite
  • Excellent written and oral communication
  • Lead auditor certified
  • Risk management training to ISO

Preferred Requirements:

  • Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ENISO13485 (Quality Management Systems), FDA and Risk Management (ENISO14971)
  • Experience in a leadership role with people management responsibility
  • Ability to work with cross-functional teams, including regulatory affairs, engineering, operations and warehousing 
  • Ability to multi-task and to work in an environment with an awareness of impact on production and the plant performance
  • Organised and resourceful with excellent attention to detail and ability to get the job done 
  • Determination and self-motivation 
  • The ability to identify and focus on methodical problem resolution
  • Ownership for your own professional development and implementation of new approaches to doing things. Emphasis on simplicity of determination

For more information and a confidential discussion about this opportunity please apply with your most recent CV for the attention of Lisa Hughes at lisa.hugh or call Osborne Recruitment on .

If you are interested in finding out more about the above role and would like to be considered other suitable roles that we may have available for your skill set – please attach your CV via the link provided
Please submit your updated CV in Word Format

If you are living in Ireland and hold a valid work permit we would love to hear from you, if however you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.