Head Of Group Medical Regulatory

　　Date: Jan 17, 2024

　　Brand: Operations OO

　　Location:

　　Agordo, IT

　　WHO WE ARE

　　We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is uniquely positioned to address the world’s evolving vision needs and the global demand of a growing eyewear industry.

　　With over 180,000 dedicated employees in 150 countries driving our iconic brands, our people are creative, entrepreneurial and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to “see more and be more” thanks to our innovative designs and lens technologies, exceptional quality and cutting-edge processing methods. Every day we impact the lives of millions by changing the way people see the world.

　　ENVISION YOUR FUTURE JOB:

　　We are looking for a profile of Head Of Medical Regulatory that will be based in our HQ Operations - Agordo (BL).

　　The position reports within the Group Quality Team, working cross-functionally with the different Company Departments in order to ensure the Group full compliance with Medical Devices Applicable Regulations at a Global Level. The perfect fitting candidate has ideally a previous experience in QARA environment with a particular focus on Regulatory aspects and Medical Devices topics.

　　Primary responsibility of the role is to be updated on MD Regulatory scenarios at Global Level, set Regulatory Company guidelines, support the Business through specific regulatory related position papers and clear technical recommendations. The selected candidate will even cover the PRRC role for the Group.

　　AREAS OF RESPONSIBILITIES AND RELATED ACTIVITIES:

　　• Manage and lead the Regulatory Status at Global level for Medical Devices topics and 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, risk management.

　　• Monitor and evaluate the effectiveness of the QMS through metrics and internal audit, with specific focus on Medical.

　　• Ensure compliance with applicable regulatory requirements and quality standards, working transversally with all the Company Departments.

　　• Provide leadership and guidance to the Quality Systems team and cross-functional teams to ensure quality objectives are met and maintained.

　　• Ensure compliance with all applicable laws, regulations, and industry standards related to Medical Devices.

　　• Collaborate with Legal, R&D, Engineering and Manufacturing, and other 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.

　　• Check the conformity of devices/products in accordance with the quality management system (QMS) the company uses before the device/product is released.

　　• Ensure that technical documentation and the EU documentation of conformity are generated and up to date.

　　• Make sure the company complies with post market surveillance obligations working with the Head of Market Technical Excellence (Article 10(10) of MDR).

　　• Be responsible for ensuring that the company fulfills its reporting obligations, found in Articles 87-91 of MDR.

　　• Manage, when needed, relationship and activities with Notified Bodies.

　　• Ontop of the role above described, the Head of Group Medical Regulatory will facilitate the integration of the GV Quality related activities leading the change in the organization.

　　NETWORK OF INTERACTION:

　　INTERNAL : Quality, Legal, R&D, Engineering, Manufacturing

　　EXTERNAL : External entities responsible for the Medical Regulatory, Retail and Wholesale teams.

　　TECHNICAL SKILLS - PORTRAIT OF A PERFECT CANDIDATE:

　　• 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 ELSE DO YOU NEED TO KNOW?

　　In EssilorLuxottica you have the feeling of being part of a “success story”, no matter where you work in the EssilorLuxottica world, you can really make an impact.

　　Are you ready for this challenge?

　　If yes, we are waiting for you.

　　Job Segment: Medical Device, Document Control, Medical, Ophthalmic, Healthcare, Administrative