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.
- 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.
- 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
- 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
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