Head of Quality Assurance and Regulatory Affairs

• Key member of the Operations Management Team and Corporate Quality Team.
• ISO9001 Management representative (ISO9000, 4.1.2.3, ISO 9001, 5.5.2), ISO 13485.
• Keep up to date of current Quality Standards and Regulations impacting the IVD industry.
• Control of the Quality Manual including preparation, revision and execution.
• Responsible for organising Management Review and compiling and reporting on the performance of the quality system.
• Ensuring that all customer specific quality requirements are compiled with following contract review.
• Management of the product review and release system and signature on Certificates of Conformity.
• Management of Change Control and Document Control Systems.
• Issuing, control and filing of all batch related documentation.
• Responsible for final sign-off on all product labels, package inserts and Marketing Material.
• The organisation of product and facility inspection, preparation of procedures and instructions including certification assessment and surveillance audits, FDA inspections, other regulatory inspections and supplier audits.
• Ensuring that validations are performed on equipment, processes and software used in manufacturing and testing of product.
• The Management of non-conformance and corrective and preventative action systems including the control of further processing and delivery of non-conforming product until any deficiencies or unsatisfactory conditions have been corrected.
• Responsible for coordination of issuing Product Safety Notifications or Product Recalls as well as Medical Device Reporting (MDR) with the Vice President of Regulatory Affairs.
• Ensure latest updates of regulatory requirements are implemented and available for use and communicated to other facilities in the Trinity
• Ensuring Compliance with worldwide regulations/ regulatory submissions.
• Key participant in design control.
• Assist with FDA regulatory submissions with the Vice President of Regulatory Affairs.
• To communicate the awareness of customer requirements throughout the organisation and to champion Quality and continuous improvement initiatives.
• To liase with external parties on matters of the quality management system.
• Ensure that Health and Safety procedures are adhered to at all times and that the company ensures that at a minimum all legislative requirements are adhered to.
• Primary degree qualification in a science, engineering or business discipline or equivalent in terms of relevant operational experience
• 5-7 years + industrial experience, three years or more in the IVD industry or similar industry is required.
• Must have experience in project management of change programs
• First hand experience of audits by regulatory authorities.
• Experience in hosting and leading FDA and other regulatory authority audits, would be an advantage.
• Extensive experience of developing and delivering effective training on Quality Systems and Processes
• Demonstrated track record and success in team building skills
• Demonstrated experience of people management
• A logical and planned approach to all tasks
• An excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused.
• An in-depth knowledge of International Standards, GLP, and GMP
• Ability to manage complex projects involving multiple functions
• Ability to gain consensus on key quality/operational decisions.
• Strong analysis/problem solving skills
• Strong attention to detail/quality focus
• Balanced cost/quality/customer focus
• Willingness and ability to collaborate with and influence other groups in a positive, team-based environment. Must also be able to hold others to account as required.
• Work with a sense of urgency and have the ability to be impartial and objective.
• Be an active learner and developer of self