Head of Medical Regulatory Operations
1 mese fa
We are seeking a highly skilled Head of Medical Regulatory to join our Operations team at EssilorLuxottica. As a key member of our Group Quality Team, you will be responsible for ensuring the company's compliance with medical device regulations at a global level. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with a focus on medical devices and a proven track record of success in a similar role.
Key Responsibilities:
Manage and lead the regulatory status at a global level for medical devices, with a focus on MDR compliance
Oversee the implementation and maintenance of policies and procedures related to quality management and control
Monitor and evaluate the effectiveness of the QMS through metrics and internal audit
Ensure compliance with applicable regulatory requirements and quality standards, working transversally with all company departments
Provide leadership and guidance to the Quality Systems team and cross-functional teams to ensure quality objectives are met and maintained
Requirements:
Educational background in engineering
At least 4/5 years of experience in quality departments
Strong problem-solving skills and fluency in English
Solid experience in QARA environment with a particular focus on regulatory aspects and medical devices topics
What We Offer:
EssilorLuxottica offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to innovation and excellence, and we are looking for talented individuals who share our values and passion for quality and regulatory compliance. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
Network of Interaction:
Internal: Quality, Legal, R&D, Engineering, Manufacturing
External: External entities responsible for medical regulatory, retail, and wholesale teams
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