Regulatory Specialist

Company: RxSight, Inc.
Location: Aliso Viejo
Posted on: June 20, 2022

Job Description:

RxSight has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. This intraocular lens can be adjusted non-invasively while in the eye, allowing the post-cataract surgery patient to see clearly at distance without the use of eyeglasses or contact lenses. The application of light to the implanted Light Adjustable Lens (LAL---) will fine-tune the patient's lens power to their specific visual need.This technology sets the stage for a series of lens products from RxSight that will have widespread application in cataract and refractive surgery as well as outside the field of medicine.
ESSENTIAL DUTIES AND RESPONSIBILITIES:This individual will function as a member of the regulatory team and will interact with other functional areas including Clinical Affairs, R&D, and Quality. --- Assist with regulatory compliance activities, including: o Evaluating product and process changes for regulatory impact o Reviewing and approving documentation such as change notices, test protocols and reports and device labeling o Performing gap analysis on newly issued consensus standards and drafting of departmental standard operating procedures, as needed o Maintain/submit facility registrations and device listings per global requirements o Responsible for submission of international export certifications and Certificates to Foreign Governments--- Assist with development of FDA and OUS regulatory submissions including IDE and PMA annual reports, Post Approval Study semi-annual reports, Technical Documentation and other OUS regulatory submissions--- Track regulatory US and OUS regulatory submissions to ensure timelines are met-Primary company liaison for all product labeling including managing changes, standards compliance, tracking, approval and translations. Must have a working knowledge of the U.S. (pre-and post-market) and OUS labeling regulations and ensure compliance with those regulations. Ensure that any modifications to approved labeling are properly reviewed with the Regulatory team and communicated with the appropriate regulatory agency, when required.--- Maintain Global Unique Device Identifier (UDI) databases--- Manage EUDAMED database -Develop understanding and maintain current knowledge of global regulatory requirementsREQUIRED KNOWLEDGE, SKILLS AND ABILITIES:--- Effective analytical and problem-solving skills with the ability to apply creative solutions to challenges.--- Solid project management skills to handle multiple projects and set/manage timelines with a high degree of urgency.--- The ability to interface effectively with all levels and functions within the organization.--- Demonstrated attention to detail.--- Excellent technical writing skills. EDUCATION, EXPERIENCE, and TRAINING:--- Bachelors degree with 2-5 years of related experience in the medical device industry.--- Training to be completed per the training plan for this position as maintained in the document control system.

Keywords: RxSight, Inc., Aliso Viejo , Regulatory Specialist, Other , Aliso Viejo, California