SRG partner with a global leader in the design/manufacture of optical medical devices. With exceptional growth plans, training opportunities, and personal development, they offer the chance for you to gain insight and inspiration from collaborating with teams all over the global.
As Senior Quality and Regulatory Compliance Manager, you will drive innovation across RC and QS across the UK manufacturing sites. With responsibility for a team, you will lead their communication with sites across the world.
BENEFITS:* 25 Days Holiday, Healthcare Cover, Life Assurance, Discounted Optical Support, Pension* Join a highly established team, with a tenure of over 20 years * Achievable progression opportunities, training and development.
RESPONSIBILITIES* Manages the Regulatory Compliance and Quality Systems team * Oversee the team in the change management process, liaising with Global & Regional RA/QA teams to complete regulatory impact assessments. * Manages Customer audits, actions and responses to be taken in relation to regulatory and third-party audits * Manages changes and improvements to the quality system to ensuring all remain compliant with applicable current and future standards and regulations. * Responsible for the internal audit process ensuring internal audits scheduled, performed, reported and non-conformances are raised appropriately. * Provide support to the Internal Audit team ensuring it is effective and adequately resourced. * Responsibility for the Quality Returns team. Ensuring customer complaints received at the hub are initiated, evaluated, investigated, reported (if required) and approved. * Assists with Adverse Event Reporting and FSCA/Recall activities, as required. * Manages the CAPA support team and process, ensuring that CAPAs are appropriately raised, resourced and progressed to effective outcomes. * Ensures that corrective actions that may affect other sites are appropriate communicated. * Drive the Management Review process, including capturing and analyzing data to ensure that the quality system remains suitable, adequate and effective. * Leads continuous improvement activities associated with Quality System processes.
EXPERIENCE/SKILLS* Strong comprehension of regulatory compliance within the medical device arena * Experience in the Quality Assurance area * Knowledge of ISO 9001/ ISO 13485, ISO 14971,21 CFR Part 820 and MDR * Quality systems experience with an understanding of corrective and preventative action eg root cause analysis, general investigating and report writing * Leadership skills
For more information, or to discuss your career in the Quality Assurance/Regulatory Affairs arena, please contact Holly Evans on email@example.com
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