Essilor of America Global Regulatory Affairs Director in France
The Instruments Division is leader in the development, manufacturing and distribution of solutions and services for eye care professionals throughout the world: fitting and mounting lenses, refraction instruments, diagnostic equipment, measuring devices, tools & consumables. Essilor Instruments aims to provide innovative solutions and technologies for diverse needs of ECPs to help them improve the efficiency and quality of their services, as well as strengthen trusted relation with their patients.
You will have the opportunity to:
Lead the regulation process for products requiring governmental approval by ensuring that all necessary applications are filed and handling all government interactions
Manage Quality System audit processes and certifications
Animate a team of regional Regulatory Affairs roles & local agencies
Your main missions:
Monitor emerging trends regarding industry regulations; and develop relationships with state or federal environmental regulatory agencies to learn about evolution of regulation. Determine potential impacts on organizational processes and on Instruments strategic roadmaps
Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Develop, manage and optimize the Quality System, ISO standards and directives including the Medical Device Directive
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
Prepare documentation and submissions to appropriate regulatory agencies
Support product verification and validation, including risk management, ISO and medical device standards validation and clinical evaluation
Implement and monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
Bachelor degree in science, engineering or related field
Proven track record in a similar role with a minimum of 8 years in medical device quality systems or equivalent in Optics Industry
Extensive knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices.
Experience in design, verification and process validation processes
Prior experience in class II medical products highly preferred
Good leadership and project management skills with the ability and willingness to effectively build and manage a small team
Excellent verbal and written communication skills
Fluent in English
Time management skills
20% of your work time in traveling
https://www.essilorusa.com/careers/diversity-inclusion Essilor of America and/or its subsidiaries is an Equal Opportunity Employer.