Head Of Group Medical Regulatory

4 settimane fa


Agordo, Veneto, Italia Luxottica A tempo pieno
Job Title: Head Of Group Medical Regulatory

We are seeking a highly skilled and experienced professional to lead our Group Medical Regulatory team. As Head Of Group Medical Regulatory, 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 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.
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.


  • Agordo, Veneto, Italia EssilorLuxottica A tempo pieno

    About the RoleWe are seeking a highly skilled and experienced Head of Group Medical Regulatory to join our team at EssilorLuxottica. As a key member of our Group Quality Team, you will be responsible for ensuring the company's full compliance with Medical Devices Applicable Regulations at a Global Level.Key ResponsibilitiesManage and lead the Regulatory...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    EssilorLuxottica: A Leader in Vision CareWe are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. Our company brings together the expertise of two industry pioneers to create a vertically integrated business that addresses the world's evolving vision needs.As a key member of our team, you will play a...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    At EssilorLuxottica Group, we are seeking a highly skilled individual to join our team as a Head of Medical Regulatory. In this role, you will be responsible for ensuring the company's compliance with medical device regulations at a global level.Main Responsibilities:• Manage and lead the regulatory status at a global level for medical devices topics, with...


  • Agordo, Veneto, Italia EssilorLuxottica A tempo pieno

    WHO WE AREWe are EssilorLuxottica, 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, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that...


  • Agordo, Veneto, Italia Operations OO A tempo pieno

    Job Summary: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...


  • Agordo, Veneto, Italia Operations OO A tempo pieno

    WHO WE ARE EssilorLuxottica is 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, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is...


  • Agordo, Veneto, Italia EssilorLuxottica A tempo pieno

    About the RoleWe are seeking a highly skilled Head of Regulatory Affairs to join our team at EssilorLuxottica.This is an exciting opportunity to lead our regulatory affairs team and ensure compliance with global medical device regulations.The successful candidate will have a strong background in quality management and medical devices, with experience in...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    Company OverviewEssilorLuxottica Group is 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 to create a vertically integrated business that addresses the world's evolving vision needs and the global demand of a growing...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at EssilorLuxottica Group. As a key member of our Group Quality Regulatory Team, you will work closely with cross-functional teams to develop and fulfill regulatory documentations and evidences.Key ResponsibilitiesProvide guidance on product development and testing,...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    Key ResponsibilitiesThe Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements and guidelines related to medical devices and pharmaceuticals. This includes preparing and submitting regulatory documents, conducting research, and maintaining accurate and complete records.Key Responsibilities:Prepare and submit...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    Job DescriptionAt EssilorLuxottica Group, we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Group Quality Regulatory Team, you will play a vital role in ensuring compliance with regulations and maintaining our position as a leader in the ophthalmic industry.Key Responsibilities:Develop and maintain regulatory...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the RoleThe EssilorLuxottica Group is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Group Quality Regulatory Team, you will work closely with cross-functional teams to develop and fulfill regulatory documentations and evidences.Key Responsibilities:Prepare and submit regulatory documents for product...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    Join Our Team as a Regulatory Affairs ManagerAbout UsEssilorLuxottica is a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We bring 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...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About UsWe are EssilorLuxottica, 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 the eyewear...

  • Automation Manager

    6 giorni fa


    Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the RoleWe are seeking an experienced Automation Manager to join our team at EssilorLuxottica Group. As Automation Manager, you will be responsible for coordinating a team of engineers and managing projects related to automatic machines and prototype development.Key ResponsibilitiesDefine Plant Business Plan for new automatic machines or modifications...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the RoleWe are seeking a highly motivated and detail-oriented Accounting Intern to join our team at EssilorLuxottica Group. As an Accounting Intern, you will be responsible for supporting the Global Business Service Team in various accounting activities, including month-end closing, balance sheet accounts reconciliation, and ensuring compliance with...


  • Agordo, Veneto, Italia EssilorLuxottica A tempo pieno

    Job DescriptionEssilorLuxottica is seeking a highly motivated and detail-oriented Compliance Specialist to join our team. As a Compliance Specialist, you will play a crucial role in ensuring our smart eyewear products meet the highest standards of quality and regulatory compliance.We are a global leader in the design, manufacture, and distribution of...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the RoleWe are seeking a highly motivated and analytical Product Market Analyst Intern to join our team at EssilorLuxottica Group. As a Product Market Analyst Intern, you will play a key role in the global programming to selected EssilorLuxottica Wholesale Customers to build 360° partnerships and maximize sell-out performances and service levels to...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the JobWe are seeking a talented Automation Engineer to join our team at EssilorLuxottica Group. As a key member of our Automation Engineer Business unit, you will be responsible for developing and implementing automation solutions to drive business growth and improve operational efficiency.ResponsibilitiesDesign, develop, and implement automation...


  • Agordo, Veneto, Italia EssilorLuxottica A tempo pieno

    About EssilorLuxotticaWe are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. Our company brings together the expertise of two industry pioneers to create a vertically integrated business that addresses the world's evolving vision needs.Job DescriptionWe are seeking a motivated and curious candidate...