Head of Quality and Regulatory Affairs - Diagnostics
Head of Quality & Regulatory Affairs Permanent
Next Generation are currently recruiting for a Head of Quality & Regulatory Affairs. Our client is a medical diagnostics manufacturer and they require candidates coming from a senior QA role.
- Management and control of the Quality System, ensuring it supports the corporate quality policy and quality objectives
- Monitor the suitability and effectiveness of the Quality System and assure compliance with current US and international regulations and ISO standards.
- Continuous improvement of the system to meet the evolving expectations of customers, business partners and regulators
- Control of QA and RA budgets and ensure company issued targets are achieved
- Appropriately escalate Quality and Regulatory issues to the Corporate VP of QA/RA
- Manage and lead the activities of Quality Team
- Knowledge and monitoring of domestic and international Quality Systems regulations and guidelines
- Communication with management team on areas of compliance/non compliance with current international regulations, policies and EC directives
- Control all audits of the Quality Management system
- Manage the communication with the regulatory authorities.
- Manage the Validation function
- Support the development and implementation of EHS projects, risk assessment, procedures and instructions and to oversight on the correct application, including self-audits in the area of responsibility
Experience and Requirements:
- Science degree
- Quality Assurance qualification essential
- 8+ years' experience in a QA role in the pharmaceutical, healthcare or medical device and in a FDA regulated environment is essential with no less than 3 years' experience working in a Senior role
- Successful preparation for and completion of premarket approval applications to the FDA.
- Successful completion of FDA audits
- Intensive knowledge of quality management systems and current International and European regulations/standards with respect to medical devices.
- Successful implementation of a Quality IT System implementation is essential
The Next Step for you:
Should this position be of interest to you please forward your CV to Dee Sweeney from Next Generation Recruitment or alternatively call on the main line.
Next Generation are specialists in Data Science, Digital Marketing, Finance, Insurance & Financial Services, IT Contract, IT Permanent, Life Sciences, Marketing, Sales, and Supply Chain & Operations
Applications are in strict confidence. Next Generation emphatically stresses, that as an organisation, will not forward your CV or any other personal details to any 3rd parties without your full prior approval.