Advanced Healthcare Technology Ltd.
Quality and Regulatory Manager
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Role Purpose
The Quality and Regulatory Manager is responsible for leading the company’s quality management and regulatory compliance activities to ensure that products are developed, manufactured, released, and marketed in compliance with applicable requirements. This is a hands-on role with broad responsibility across the quality management system, technical documentation, post-market activities, supplier quality, internal auditing, and regulatory support for global market access. The jobholder will work closely with senior leadership and cross-functional teams to maintain compliance with applicable international medical device regulations and standards, including ISO 13485, MDSAP, and relevant market-specific requirements.
Key Responsibilities
- Maintain and continuously improve the company’s Quality Management System in line with ISO 13485, MDSAP, and applicable regulatory requirements.
- Manage the relationship between the company and key regulatory bodies including the company’s Notified Body / Auditors.
- Ensure products are correctly classified for regulatory clearance in proposed markets.
- Support and maintain technical documentation, declarations of conformity, labelling compliance, and product records in line with product classification.
- Act as the internal lead for quality assurance and regulatory compliance.
- Plan and conduct internal audits and support external audits by certification bodies, regulatory authorities, customers, and other third parties.
- Manage non-conformances, deviations, CAPA, complaints, and change control processes.
- Support clinical evaluation and human factors processes to ensure that these are met throughout the product life cycle.
- Support post-market surveillance, vigilance reporting, field safety corrective actions, and trend analysis where required.
- Ensure document control processes are effective and that quality records are complete, accurate, and audit-ready.
- Work with Senior Management to ensure culture of compliance is embedded in business processes.
- Support supplier qualification, monitoring, and re-evaluation activities, including supplier audits where appropriate.
- Provide regulatory input for product changes, new product introduction, and international market expansion.
- Monitor changes in applicable regulations, standards, and guidance and assess their impact on the business.
- Coordinate management review inputs, quality metrics, and compliance reporting for leadership.
- Deliver training and guidance to staff on quality and regulatory requirements and promote a strong quality and compliance culture.
- Support product registration and market access activities in territories where the company sells its products, using external specialists where required.
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Management Responsibilities
- Direct Reports – Currently none
- Consultants and contractors – as appropriate
Qualifications and Experience
- Degree or equivalent experience in a relevant scientific, engineering, quality, or regulatory discipline.
- Lead Auditor qualified or extensive experience with internal auditing, CAPA, complaints handling, supplier quality, and change control.
- Proven experience in quality assurance and regulatory affairs within the medical device sector.
- Strong working knowledge of ISO 13485 and medical device regulatory requirements relevant to Class I and II devices especially in the USA.
- Experience maintaining technical documentation and quality system records in a regulated environment.
- Experience supporting international regulatory compliance and market access activities is essential.
- Supervise quality and document control activities.
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Key Skills and Attributes
- Ability to work independently and pragmatically in an environment with limited resources.
- Strong organisational skills, attention to detail, and the ability to prioritise across multiple responsibilities.
- Confident communicator able to work effectively across departments and with external stakeholders.
- Ability to interpret regulations and translate them into workable internal processes.
- Strong problem-solving and root cause analysis skills.
- Ability to influence without unnecessary bureaucracy.
- Comfortable balancing compliance requirements with business needs and operational realities.
- High integrity, accountability, and commitment to patient safety and product quality.
Reporting and Working Relationships
This role reports to the Managing Director.
Key relationships with manufacturing, engineering, supply chain, customer service, and commercial teams.
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