The Quality Assurance & Regulatory Affairs (QA/RA) Manager is responsible for maintaining and reviewing the Quality Management System and quality assurance functions
The objective is to drive a behavioral approach across the business and develop the process owners to take ownership of their SOPs.
Drive continuous improvement activities within the QMS and Identify risk to the business to Senior Managers.
Lead all audit processes by the regulators to ensure certification of ISO 9001 and ISO 13485 and compliance to FDA 21 CFR Part 820.
The QA/RA Manager will also be responsible for product registrations, technical file submissions pre region and Regulatory Authority requirement, medical device reporting, documentation, and approvals to support product lifecycle management and market expansion.
The QA/RA Manager will be the Management Representative and Person Responsible for Regulatory Compliance for Mangar International Ltd and will interact with all departments to ensure that our devices meet EU MDR, FDA and other global regulatory requirements, supporting product development from concept through post-market activities.
This role reports to the Head of R&D and has a close working relationship with Mangar Internation Ltd Site Manager.
KEY TASKS & ACCOUNTABILITIES
• Responsible for ensuring that the Company’s Quality Management System (QMS) conforms to the requirements of international standards (ISO 9001 & ISO 13485) and compliant to FDA 21 CFR Part 820.
• Lead on Management Reviews, Feedback, Complaints, CAPA.
• The Company’s Quality Management Representative (QMR).
• Companies Person Responsible for Regulatory Compliance (PRRC).
• Registration of the company’s medical devices with applicable competent authorities.
• Vigilance reporting e.g., medical device adverse incidents to the applicable competent authorities.
• Maintain relationships with the Client's Quality Representatives and any 3rd party regarding quality matters.
• Lead on company quality and monitor the process owners to ensure the company’s processes are delivering their intended outputs.
• Supports the process owners to monitor, report and improve their processes and training of applicable procedures.
• Responsible for reporting on the performance, suitability and effectiveness of the QMS and on opportunities for improvement, to senior management team.
• Conduct, lead and develop audit schedules
• Responsible for ensuring the promotion of customer and patient focus throughout the organisation.
• Quality sign off on product development lifecycle documentation and activities (as appropriate)
• Authorisation/co-ordination of concessions for release of products not covered in standard processes, re-work of any components identified as out of specification (as appropriate based on risk/impact to the company)
• Regulatory Compliance: Ensure ongoing compliance with applicable medical device regulations, standards, and guidance documents across the lifecycle of each product. Maintain knowledge of current and emerging regulations and communicate updates to relevant stakeholders.
• Labelling and UDI Compliance: Review and approve labelling to ensure compliance with regulatory requirements, including UDI requirements. Collaborate with marketing and product teams to ensure accurate product labelling and documentation.
• Support risk management activities and ensure that risk assessments are documented, reviewed.
• Post-Market Surveillance and Vigilance: Assist in post-market surveillance activities, including adverse event reporting, field safety corrective actions, and product recalls, in compliance with MDR, FDA and other global regulatory requirements.
• Cross-Functional Collaboration: Partner with R&D, Quality, Regulatory Affairs, and Marketing teams to ensure requirements are integrated into product development and maintenance processes.
• Training of practices and procedures to cross-functional colleagues within the business as and when required.
Health, Safety and Welfare
It is the postholders responsibility to ensure compliance with all safety procedures and safe working practices, including environmental awareness, wearing of appropriate PPE and uphold all safe working practices and required behaviors.
In addition, all colleagues are required to report any malpractice, breaches or potential risks and contribute to the health, safety and welfare of all colleagues and site visitors.
Skills, Qualifications and Experience
• Education: A degree, preferably in; Life Sciences, Biomedical, Pharmaceutical, Engineering, or a related field.
• commercial experience in Quality Assurance within the medical device industry, with a focus on EU MDR and FDA compliance.
• Knowledge: Strong understanding of EU MDR, as well as international standards & regulations (ISO 13485:2016 & FDA 21 CFR Part 820 etc.).
• Skills:
o Strong managerial skills, with the ability to get the best from team and external team members and efficient delegation when required.
o Strong project management and organisational skills with the ability to handle multiple projects simultaneously and priorities tasks.
o Excellent written and verbal communication skills, with attention to detail in documentation.
o Ability to interpret standards and communicate requirements effectively to cross-functional teams.
• Travel: UK drivers’ license & willingness to travel between company and customer sites as and when required
