Quality Assurance and Regulatory Expert
About the Role:
* We are seeking an experienced Quality Assurance and Regulatory Expert to lead all quality and regulatory activities, ensuring compliance with international standards, regulatory requirements, and health and safety legislation.
* The successful candidate will be responsible for developing, implementing, and maintaining the Integrated Management System (IMS) to ensure compliance with ISO 9001, ISO 13485, ISO 27001 certifications, and ISO 17025 accreditation.
* They will integrate QMS processes across sites to streamline operations and maintain consistency.
* The expert will conduct internal audits and coordinate external audits, ensuring timely closure of findings.
* They will manage corrective and preventive actions (CAPAs) and lead CAPA teams.
* Oversight of document control and change control processes is also a key responsibility.
* The Quality Assurance and Regulatory Expert will validate new equipment and materials, including training and monitoring.
* They will ensure compliance with MDR/IVDR, GDP guidelines, and applicable health regulations.
* The expert will manage product registration and regulatory submissions via EUDAMED and MHRA.
* Monitoring regulatory changes and updating internal policies accordingly is also a key responsibility.
* The Safety Officer will acknowledge and ensure compliance with company Safety Statement and Risk Assessments.
* Providing health and safety training with external consultants and ensuring protective equipment is available are key responsibilities.
* The expert will monitor workplace safety and implement risk mitigation measures.
* Supplier onboarding, qualification, and performance monitoring are also key responsibilities.
* The Quality Assurance and Regulatory Expert will ensure supplier compliance with quality standards and resolve quality issues promptly.
* Reviewing product specifications and disposition decisions (acceptance/rejection) is a key responsibility.
* Built strong relationships with customers on quality and regulatory matters.
* Implementing and maintaining ISO 27001 standards for information security is also a key responsibility.
* The expert will ensure confidentiality, integrity, and availability of information assets.
* Leading and developing the Quality & Regulatory team, providing coaching and feedback are key responsibilities.
* Driving continuous improvement initiatives across quality and compliance processes is a key responsibility.
* Monitoring KPIs and reporting progress to senior management is also a key responsibility.
Requirements:
* Proven experience in quality assurance and regulatory affairs.
* Strong knowledge of international standards, regulatory requirements, and health and safety legislation.
* Experience in developing, implementing, and maintaining IMS.
* Ability to integrate QMS processes across sites.
* Excellent communication and leadership skills.
* Ability to work under pressure and meet deadlines.
Benefits:
* Opportunity to work in a dynamic and challenging environment.
* Professional development and growth opportunities.
* Competitive salary and benefits package.
How to Apply:
1. Submit your application, including your resume and cover letter.
2. Contact us to discuss the role further.