POSITION TITLE: Manager of Quality and Regulatory Assurance
DEPARTMENT: Quality
REPORTING TO: Director of Quality, Regulatory and Innovation
POSITION OVERVIEW
Overseeing and managing all aspects of quality assurance, regulatory compliance, and ensuring adherence to industry standards such as ISO 13485, ISO 11607, and the Medical Device Regulation (MDR).
Understanding of regulatory requirements in the medical device industry and the ability to develop and implement effective quality systems to ensure compliance and product excellence.
Compliance with ISO 13485: maintaining and improving the quality management system; all employees contribute to this aspect where reasonable and depending on the scope of the position responsibilities.
Documentation and Record Keeping: creation, maintenance, and management of quality-related documents and records; adherence to document best practices as described in internal procedures critical towards ISO 13485 compliance.
Effective communication with other departments, management, and regulatory authorities regarding quality issues and compliance with ISO 13485.
KEY RESPONSIBILITIES
Involved in the day-to-day operations of the Quality function, including but not limited to:
Provide overall leadership to the team and foster a diverse, entrepreneurial environment that enables all participants to contribute to their fullest potential in pursuit of organisational goals and objectives.
Provide quality leadership for product development teams delivering next generation products to the market.
Guide, coach, recruit, and develop organisational talent.
Monitor and ensure compliance with company policies and procedures through the implementation of a robust quality system and communication/reporting to regulatory authorities in conjunction with the Regulatory Group.
Work in partnership with R&D to support design enhancements for existing products.
Ensure product safety, reliability, and quality through the effective use of planning, risk assessment, statistical methods, and process control during the design and manufacturing stages of the product lifecycle.
Manage and maintain compliance to ISO13485 requirements.
Responsible for responding and reporting incidents to all approved markets.
Establish, manage and maintain compliance with QSR, including establishment registration, new product submissions, CAPA System.
Establish, manage and maintain compliance with medical device Regulation (EU) 2017/745, including CE Mark applications via Technical Files.
Ensure continuous improvement in product performance by incorporating learnings into new product development.
Develop yearly target budget and capital plan.
Manage QA & RA expenditure against budget.
Employ lean methodologies to improve the efficiency of the Quality System.
Provide direction to project teams and engineers in the processing and development of protocols, reports, procedures, deviations and change requests on a day-to-day basis for identified projects.
Act as the management representative; point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.
Person Responsible for Regulatory Compliance – MDR 2017/745.
QUALIFICATIONS, KNOWLEDGE and SKILLS
A graduate of Engineering/Sciences.
Extensive knowledge of quality management systems and current international and European regulations/standards with respect to medical devices.
Demonstrable ability to work in a multi-disciplinary, regulated environment.
RELEVANT EXPERIENCE
5 years' experience in a Pharmaceutical / Medical Device environment.
Minimum of 3 years of people management experience.
2 year working knowledge of ISO 13485.
Min of 1 year working knowledge MDR 2017/745.
PERSON SPECIFICATION AND CORE COMPETENCIES
Excellent interpersonal and communication skills with good leadership abilities.
High level of self-motivation.
Honed decision making, applying pragmatism and organisational understanding to operational decisions.
Team player with strong work ethic.
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