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Quality Assurance and Regulatory Affairs Manager
Our client is looking for a Quality Assurance and Regulatory Manager to join their growing business.
Ensuring all regulatory activities directly relating to the safety and efficacy of the products are manufactured and distributed on site are conducted in compliance with the current international regulations in the markets where the product is used. Also updating and maintaining a Quality Management System in compliance with the changing international standards and regulations.
- Ensuring business is compliant with the correct standards where our product is used
- Quality Management System - Update and maintain procedures where necessary to remain quality compliance with external regulatory agents
- To support R&D and Manufacturing activities normal day to day running of manufacturing,
- Maintaining an effective management of CAPAs, Non-Conformities, Customer Complaints processes
- Maintaining an effective management of Change Control, Risk management and project processes
- Management Representative hosting and primary lead on external agencies technical audits
- Overseeing, organising, carrying out of internal and supplier audits
- Responsible for notification of significant changes that affect quality system and implementation of necessary actions
- Overseeing compliance of sterilisation activities
- Product quality authority sign-off responsibility
- Ensure the regulatory standards are followed
- Ensure effective management of all post market activities
- Compiling and maintaining of European, US, Canadian and other international submissions for sale of product.
- Primary contact for international distributors;
- Hosting and primary lead on 3rd party regulatory audits.
- Liaison with Competent Authorities, Notified Bodies, distributors, customers and internal departments
- Product regulatory authority sign-off responsibility
- Maintenance and renewal of international licences
- Ensuring that sufficient resource is allocated to review, understand, and update to comply with harmonised standards, regulations, directives, and guidance
- To allocate and lead the champions for External Standards
- Managing team and providing support as and when required
- Coaching and mentoring of team members
- Adhering and promoting Health and Safety requirements
- Adhering to Company policies and Procedures
Matchtech acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers and is part of Gattaca Plc.
Gattaca Plc provides support services to Matchtech and may assist with processing your application.
You can not apply for this job as its status is Closed.