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Description:

Quality, Environmental and Regulatory Affairs Manager

Job Purpose:

As a quality manager, you’ll coordinate the activities required to meet the quality standards set for certain products or services. You’ll ensure that this quality is consistent and meets both external and internal requirements.

Your role is concerned with monitoring and advising on the performance of the quality management system, producing data and reporting on performance, measuring against set standards.

To ensure the Quality and Environmental Management System (QEMS) is managed, monitored, developed and maintained, ensuring compliance with all applicable regulatory requirements.

As regulatory affairs manager the role is focused on completing gap analysis, completing remedial tasks, knowing MDR and UKCA regs for full technical file build (Clinical, risk, biological evaluations), and to be able to maintain the ISO13485 QMS system.

Main Activities:

As a quality and environmental manager, you’ll need to:

• maintain and update the company’s quality procedures, standards and specifications.
• review customer requirements and make sure they are met.
• work with purchasing staff to establish quality requirements from external suppliers.
• set standards for quality.
• make sure that manufacturing or production processes meet international and national standards.
• Identify ways to reduce waste and increase efficiency.
• define quality procedures in conjunction with operating staff.
• set up and maintain controls and documentation procedures.
• monitor performance by gathering relevant data and produce statistical reports.
• review existing policies and make suggestions for changes and improvements and how to implement them.
• measure performance and identify any areas of weakness, recommending and implementing improvements.
• liaise with other managers and staff and provide training, tools and techniques to enable others to achieve quality standards.
• assess the effectiveness of changes made.
• make sure the company is working as effectively as possible to keep up with competitors.
• Completion of risk management to ISO 13485 standards.
• Maintain procedures required by medical device.
• Monitor daily quality performance.

As a quality and environmental Manager, you’ll need to:

• Provide regulatory advice to obtain or maintain CE marking to EU medical device Regulation (EU/2017/745)
• Provide UKCA guidance to regulation (MDR2002)for medical devices classes I, IIa, IIb and III.
• Reviewing, collating, revising and updating technical files to meet UK and EU regulatory requirements.
• Risk management to ISO14971:2019
• Post market surveillance reports and plans.
• Post market clinical follow up.
• Communication with notified bodies and competent authorities.

KPI’s and Monitoring:

All KPI’s will be reported to the Operations Director once per month, prior to our Monthly Meeting.

• Customer Complaints
• Returns from Customers
• Audit performance / Adherence to schedule
• Time to completion of internal CAPA
• Time to complete external audit corrective actions