Quality and Regulatory Manager

At Medicareplus, we pride ourselves on being a leading force in advanced wound care and infection prevention. Our mission focuses on creating innovative products that enhance patient care and support healthcare professionals. Join us in our commitment to excellence and become part of a culture that values collaboration and innovation.

We are seeking a Quality and Regulatory Manager (QA/RA) who will report directly into the Chief Financial Officer. The Quality and Regulatory Manager will be responsible for ensuring continued compliance of the Company's Quality Management System with the relevant Medical Device Directives, Medical Device Regulations, International Standards, and Customer Requirements and provide knowledge and support to the company to enable it to operate within all the applicable Regulatory Guidelines.

Hours of work: Monday to Friday, based at our London HQ in Alperton, 8.30am - 5pm.

Qualifications and experience:

• Qualification in life sciences or engineering (BSc, or BEng)
• 4 years of experience in a regulatory compliance role in the medical device industry
• Specific experience in regulatory affairs and submissions in the UK, European, Canadian and American markets is required
• Experience in dermatology products is desirable
• Qualification or experience as a microbiologist is desirable

Responsibilities:

• The Quality and Regulatory Manager will act as the person responsible for regulatory compliance within the definition of the EUMDR 2017/745.
• Lead and mentor the QA team: Manage, train, and develop the QA/RA team, including hiring, performance reviews, and fostering a collaborative, results-driven environment.
• Allocate resources: efficiently manage the team's workload, budget, and resources to meet project timelines and quality goals.
• Manage all aspects of Quality and Regulatory compliance.
• Manage Preparation and Maintenance of Product Registrations and Regulatory Files.
• Oversee the Department's Management and promotion of the Quality System.
• Operate the Quality Management System in compliance with the current ISO 13485.
• Prepare and present Quality Data to analyse quality trends and support investigations, remediation, report and agree improvement initiatives.
• Ensure that the company's Quality Policy and set objectives are met; plan and implement monitoring, measurement, analysis, and improvement of quality performances of the organisation.
• Oversee the maintenance of the Technical Files and Documentation.
• Responsible for the Document Control process and the efficient control of all documentation required by regulatory agencies.
• Plan and manage internal audit activities and continuous improvement and coordinating audit corrective actions.
• Oversee the management of the CAPA process to ensure corrective actions are established and that root-cause elimination is completed for identified issues.
• Supervise and oversee the management of the complaint handling process and medical device reporting activities and post-market surveillance.
• Oversee the management of the Non-Conformance process.
• Author and approve the Standard Operating Procedures and work instructions.
• Providing the necessary training to ensure employees understand QMS.

Benefits:

• Competitive salary with a performance-related bonus.
• Comprehensive benefits package.
• Opportunities for professional development and progression within a leading organisation.

If you think you are suitable for this role, please apply now for an opportunity to influence change and drive success within a company that is dedicated to improving lives.