Regulatory Affairs Manager

Job title:

Regulatory Affairs Manager

Company:

EssilorLuxottica

Job description

WHO WE AREWe 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:The position reports within the Group Quality Regulatory Team, working cross-functionally with the different Company Departments and collaborating with cross-functional teams, including research and development, engineering, manufacturing and legal departments, to develop and fulfill regulatory documentations and evidences. Provides guidance on product development and testing, ensuring that all necessary studies and trials are conducted to demonstrate safety and efficacy.Primary responsibility of a Regulatory Affairs Manager is to prepare and submit regulatory documents for product approval. This includes compiling data from various sources, conducting research, and ensuring compliance with regulations. He/She meticulously reviews and organizes all necessary information, ensuring that it is accurate, complete, and meets the requirements set by regulatory authorities.
Additionally, Regulatory Affairs Manager is responsible for keeping up-to-date with regulatory changes, monitoring industry trends, and ensuring that the company remains in compliance with changing regulations. He/She reviews labeling and promotional materials to ensure accuracy and compliance, as well as prepare reports for regulatory authorities.
A Regulatory Affairs Specialist plays a crucial role in ensuring that medical products meet the necessary regulatory requirements before they can be approved for sale or distribution. These professionals work closely with regulatory agencies, such as the Food and Drug Administration (FDA), to navigate the complex landscape of regulations and guidelines. He/She serves as the bridge between the company and regulatory authorities, ensuring that all necessary documentation and information are provided for product approval.The perfect fitting candidate has a previous experience in QARA environment with a particular focus on Regulatory aspects and Medical Devices topics under FDA and MDR Regulations.AREAS OF RESPONSIBILITIES AND RELATED ACTIVITIES:

• Planning and organization – Strong attention to details
• Excellent communication skills (written and verbal) to effectively communicate with both internal teams and regulatory authorities
• Analytical critical thinking and problem solving
• Analytical skills to interpret complex regulations and scientific data.
• Ability to analyze information, identify potential risks, and propose effective regulatory strategies
• Ability to create and manage the proper technical folder with all the evidences needed for an Authority submission
• General understanding of scientific and regulatory principles, with a solid foundation in medical terminology, as well as knowledge of the medical product development process and regulatory requirements specific to the industry
• Manage regulatory submissions for international markets: ability to prepare and submit regulatory documents in an effective and complete way to match Company timeframes with Authority expectations and excellent standard
• Ability to work under pressure and to tight deadline
• Good understanding of regulatory requirements and current industry practices
• Good knowledge of US FDA and CE marking (MDR), as well as quality management systems such as ISO 13485 and ISO 9001
• Maintain and update regulatory files and databases
• Ensure compliance with all applicable regulations and guidelines, monitoring changes in regulatory requirements and communicate updates to relevant departments
• Supporting review and approval of product labeling and advertising materials
• Participate in regulatory inspections and audits
• Liaise with regulatory agencies and respond to inquiries
• Review and approve clinical trial protocols and reports
• Provide regulatory support during product recalls and other compliance issues

PORTRAIT OF A PERFECT CANDIDATE:

• Bachelor’s Degree in a scientific field such as Biochemistry, Chemistry, Engineering, Pharmacy or Molecular Biology preferred
• 5 years plus of experience in a similar role
• Minimum of 5 years of experience with regulatory submissions for both domestic and international markets
• Strong history of Submissions managed for medical devices (FDA & MDR)
• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)

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.

Expected salary

Location

Agordo, Belluno

Job date

Thu, 26 Dec 2024 03:05:14 GMT

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