Regulatory Affairs Expert for Medical Devices
11 ore fa
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.
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