Quality and Regulatory Manager

Position Overview:

The Quality and Regulatory Manager is responsible for overseeing the organisation’s quality assurance processes and ensuring full compliance with industry regulations and internal standards. This role requires a strategic approach to ensuring that the company’s products, services, and operations meet both customer expectations and legal requirements. The ideal candidate will be a proactive leader who can drive continuous improvement initiatives while ensuring compliance and quality standards are consistently maintained across the organisation.

The ideal candidate will be suited to extending the current scope of the ISO13485:2016 certification to include "Manufacturing" as the business continues to grow and Internationalise it's sales efforts.

Key Responsibilities:

Quality Assurance & Control:

• Develop, implement, and maintain the company’s Quality Management System (QMS) to ensure adherence to industry standards (e.g., ISO, FDA, MDR).
• Conduct internal quality audits and inspections to evaluate compliance with established quality standards, identify areas for improvement, and follow up on corrective actions.
• Manage the lifecycle of quality processes, from initial design to final delivery, ensuring the delivery of high-quality products and services.
• Analyse quality data and implement performance improvement initiatives as necessary to ensure consistent quality outputs.

Regulatory Compliance:

• Ensure the company remains compliant with all applicable local and international regulatory requirements.
• Monitor regulatory changes and lead efforts to align internal processes and documentation accordingly.
• Prepare and manage submissions, certifications, and responses for regulatory inspections, audits, and certifications.
• Act as the liaison between regulatory authorities, external auditors, and internal stakeholders, managing audit schedules and outcomes.

Training & Development:

• Design and deliver training programs to educate employees about quality and compliance standards.
• Provide guidance and mentorship to staff on best practices for ensuring compliance and maintaining quality standards.
• Foster a culture of quality and compliance by instilling a strong understanding of regulatory requirements across all departments.

Documentation & Reporting:

• Oversee the creation, maintenance, and review of all quality-related documentation, including procedures, protocols, and reports.
• Prepare detailed reports for Senior Management / Executive Team on quality audit results, regulatory status, and compliance initiatives.
• Maintain accurate records of quality checks, audits, training sessions, corrective actions, and regulatory compliance.

Risk Management:

• Identify potential risks to product quality or compliance and develop strategies to mitigate those risks.
• Conduct risk assessments to evaluate and prioritise quality and compliance issues.
• Lead initiatives to resolve non-compliance issues and implement long-term preventive measures.

Cross-Functional Collaboration:

• Work closely with departments such as Engineering, R&D, Procurement, and Customer Service to ensure that Quality and Compliance standards are embedded throughout the organisation.
• Collaborate with stakeholders to resolve quality issues and streamline processes to enhance overall compliance.

Qualifications:

Education:

• Bachelor’s degree in Quality Assurance, Regulatory Affairs, Life Sciences, or a related field (Master’s degree preferred).

Experience:

• Minimum of 5 years of experience in Quality Management, Regulatory Compliance, or a related field within Healthcare, Medical Device Manufacturing or Pharmaceuticals.
• Proven experience in managing audits, compliance processes, and risk management strategies.
• Familiarity with industry-specific standards, such as ISO13485:2016, FDA regulations, or other relevant frameworks.

Skills:

• Strong knowledge of ISO13485:2016 Quality Management Systems (QMS), Regulatory requirements, and industry best practices.
• Excellent leadership, communication, and organisational skills.
• Ability to interpret and apply complex regulatory requirements effectively.
• Strong analytical and problem-solving abilities, with a detail-oriented approach.
• Proficiency in using Quality Management Software and tools, as well as Microsoft Office Suite.
• Ability to manage multiple priorities in a fast-paced environment.

Physical Requirements:

• Ability to sit, stand, and move about the office or production environment.
• Occasional travel may be required for audits, inspections, or site visits.

Work Environment:

The position will be based in a office/production/warehouse environment, with occasional travel to manufacturing sites or external partner sites. The role will involve working closely with cross-functional teams to ensure seamless integration of quality and compliance processes.