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Head of Medical Regulatory
2 mesi fa
About the Role:
We are seeking a highly skilled and experienced Head of Medical Regulatory to join our team at EssilorLuxottica Group. As a key member of our Quality Team, you will be responsible for ensuring the company's compliance with medical device regulations at a global level.
Key Responsibilities:
- Manage and lead the regulatory status at a global level for medical devices, with a specific focus on MDR.
- Oversee the implementation and maintenance of policies and procedures related to quality management and control, including document control, change control, and risk management.
- Monitor and evaluate the effectiveness of the QMS through metrics and internal audit, with a specific focus on medical devices.
- 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.
- Collaborate with Legal, R&D, Engineering, and Manufacturing departments to ensure quality requirements are incorporated into product development, production, and post-market activities.
- Participate in regulatory inspections and support resolution of any quality-related issues.
- Ensure that technical documentation and EU documentation of conformity are generated and up to date.
- Manage relationships and activities with Notified Bodies, as needed.
Requirements:
- Education in Engineering or a related field.
- At least 4-5 years of experience in Quality Departments, with a focus on regulatory aspects and medical devices.
- Strong problem-solving skills and fluency in English.
About EssilorLuxottica Group:
We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. Our company brings together the complementary expertise of two industry pioneers to create a vertically integrated business that addresses the world's evolving vision needs and the global demand of a growing eyewear industry.
What We Offer:
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. Our team is committed to innovation, quality, and customer satisfaction, and we are looking for like-minded individuals to join us.
