Compliance and Quality Assurance Leader
Job Overview:
We are seeking a highly skilled Compliance and Quality Assurance professional to join our team. The successful candidate will be responsible for developing, implementing, and maintaining our Integrated Management System (IMS) ensuring compliance with international quality standards.
Key Responsibilities:
* Develop and implement the IMS, ensuring compliance with ISO 9001, ISO 13485, ISO 27001 certifications, and ISO 17025 accreditation.
* Lead corrective and preventive actions (CAPAs) teams and oversee document control and change control processes.
* Validate new equipment and materials, including training and monitoring.
* Ensure compliance with medical device regulations (MDR/IVDR), GDP guidelines, and applicable health regulations.
* Manage product registration and regulatory submissions via EUDAMED and MHRA.
* Monitor regulatory changes and update internal policies accordingly.
Leadership & Continuous Improvement:
* Lead and develop a quality-focused team, providing coaching and feedback.
* Drive continuous improvement initiatives across quality and compliance processes.
Requirements:
* Master's degree in Science, Quality Management, or related discipline.
* 5+ years experience in Quality Assurance and Regulatory Affairs within healthcare, medical devices, or pharmaceutical sectors.