Regulatory Affairs Expert for Medical Devices

11 ore fa


Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

Company Overview

EssilorLuxottica 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 eyewear industry.

About the Role

We are seeking an experienced Regulatory Affairs Manager to join our Group Quality Regulatory Team. This role involves working cross-functionally with various departments and collaborating with research and development, engineering, manufacturing, and legal teams to develop and fulfill regulatory documentations and evidences.

Main Responsibilities

  • Prepare and submit regulatory documents for product approval, including compiling data from various sources, conducting research, and ensuring compliance with regulations.

  • Review and organize all necessary information to ensure it is accurate, complete, and meets the requirements set by regulatory authorities.

  • Monitor regulatory changes, industry trends, and ensure the company remains in compliance with changing regulations.

  • Review labeling and promotional materials to ensure accuracy and compliance.

  • Prepare reports for regulatory authorities.

Requirements

  • A bachelor's degree in a scientific field such as biochemistry, chemistry, engineering, pharmacy, or molecular biology.

  • At least 5 years of experience in a similar role, preferably with regulatory submissions for both domestic and international markets.

  • Strong history of submissions managed for medical devices (FDA & MDR).

  • Familiarity with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

What You Will Enjoy

The EssilorLuxottica Group offers a dynamic and supportive work environment, where you can make a real impact. If you have a passion for regulatory affairs and a desire to work for a leading company in the eyewear industry, we would love to hear from you.



  • 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 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 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

    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 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

    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 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 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 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 Luxottica A tempo pieno

    Job Title: Head Of Group Medical RegulatoryWe 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...


  • 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 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

    About the Role: We are seeking a highly skilled Product Design Engineer to join our team in the development of innovative smart eyewear. As a key member of our R&D team, you will be responsible for designing and developing complex mechanical solutions for our wearable devices. Key Responsibilities: Develop and design complex mechanical solutions for smart...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    Are you a taxation expert looking for a new challenge? We're seeking a skilled Indirect Tax Specialist to join our Global Business Service Team at EssilorLuxottica Group. In this role, you'll support our colleagues in various activities related to VAT and withholding compliance for our European subsidiaries. Your responsibilities will include fiscal support...


  • 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 A tempo pieno

    About the RoleWe are seeking a highly motivated and detail-oriented individual to join our Operations HQ in Agordo, Italy, as a Quality Compliance Smart Eyewear intern. As a key member of our team, you will play a crucial role in ensuring compliance with international, test standard, and local regulations related to smart eyewear.ResponsibilitiesStudy and...


  • 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...

  • Senior Process Engineer

    3 settimane fa


    Agordo, Veneto, Italia https:www.energyjobline.comsitemap A tempo pieno

    ROLE SUMMARYWe are seeking a highly skilled Senior Process Engineer to join our Operations Headquarters in Agordo, Italy. As a Surface Modification Expert, you will be responsible for developing and implementing surface modification processes to improve product quality and efficiency.Your key responsibilities will include:Designing and implementing surface...


  • Agordo, Veneto, Italia EssilorLuxottica Group A tempo pieno

    About the RoleWe are seeking a highly motivated and detail-oriented individual to join our team as an Automation Quality Performance Lab Intern. As a key member of our research team, you will play a crucial role in designing and implementing robotic systems for quality testing applications in the fields of eyewear, packaging, and wearable...