My client is now looking for a Head of QA/RA to join their growing business . This role would make you a member of the Senior Leadership team, Providing QA/RA leadership and managing OEM manufacturing partner. Taking part in management representative and person responsible for regulatory compliance for the business,
• Providing strong but pragmatic regulatory and quality leadership in the business
• Implementation and maintenance of the business compliance and quality system to MDR 2017/745
• Accountable for the development and implementation, at a global level, of the regulatory and quality strategy for the business, and for ensuring that the strategy is designed to deliver a rapid
• Leading and developing a global regulatory and compliance strategy that is reflective of applicable domestic and international requirements including Quality management and compliance system requirements
• Developing registration strategies and driving the execution of registration plans for development, regulatory approval and optimal market access globally as required
• Serving as the point of contact with regulators including NBs, NCAs, certification bodies, etc.
• Development and management of the RAQA team
• Management Representative and PRRC and undertaking due diligence activities as required (implementing the relevant strategy in subsidiaries where direct management representatives may be more appropriate
• To support the complete life-cycle of business’s product portfolio from concept to design transfer, ongoing engineering efforts, and production support including lifecycle management.
• To be the primary RAQA representative on product development projects.
• To support the creation of product and component specifications and inspection requirements.
• Knowledge of the Medical Device Directives 93/42/EEC, Medical Device Regulation 2017/745, QSR 21 CFR 820
• Demonstrable regulatory or quality leadership in a similar business environment
• Demonstrable ability to gather, analyse and interpret quality management and regulatory information and changes in the regulatory landscape
• Experience of implementing regulatory strategy for QMS, CE marking, 510k applications including creation, applications and update
• Experience of conducting internal audits & hosting external audits
• Experience of managing regulatory change small business units Experience of liaison and communication with Competent Authorities and Notified Bodies
Buckinghamshire, Hertfordshire, Cambridgeshire, Bedfordshire & London.