Join to apply for the Quality & Regulatory Manager role at Medicareplus International Ltd
This range is provided by Medicareplus International Ltd. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
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.
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 the complaint handling process and medical device reporting activities and post-market surveillance
* Oversee the management 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
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