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Director, Regulatory Affairs
4 months ago
RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world’s first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company’s mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results for every unique eye.
OVERVIEW:
Reporting to the SVP, Clinical and Regulatory Affairs, the Director, Regulatory Affairs will collaborate in the development and implementation of world-class regulatory program for the RxSight technology and product offerings. Key responsibilities will include preparation, analysis, and submission of dossiers to various governing agencies in support of business growth.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
This individual will function as a member of the regulatory team and will interact with other functional areas including R&D, Manufacturing, Quality Assurance and Commercial. Responsibilities include:
• Preparing international regulatory submissions and FDA submissions which may include Technical Documents, Technical Files, Device License Applications and Amendments, and PMAs
• Identifying and gathering data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant global regulatory requirements
• Responsible for creation and annual update of Clinical Evaluation Report including State of the Art and Subject Literature Review
• Key contributor responsible for the preparation and review of regulatory submissions consistent with US and OUS regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review
• Serve as a subject matter expert on regulatory affairs and provide training and guidance to team members, as needed
• Author and/or review regulatory procedures and update as necessary
• Strong understanding of regulatory requirements for medical devices, including FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), ISO standards (e.g., ISO 13485, ISO 14971), and international regulatory frameworks
• Excellent communication skills and ability to collaborate effectively with cross-functional teams
• Participate on cross-functional project teams and act as global regulatory advisor
• Review technical documentation for suitability to support regulatory applications
• Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the company's products
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
• This role requires strong experience with premarket regulatory activities in the US, EU and other global markets.
• Proven track record of successful regulatory submissions and interactions with regulatory agencies (FDA, Notified Bodies, etc.).
• Ability to thrive in a fast-paced environment
• High integrity and character and be a person who is tough minded, fair and principled.
• Creative technical skills that lead to innovative approaches to the development process.
• Effective analytical and problem-solving skills with the ability to apply creative solutions to challenges.
• The ability to establish priorities and build enthusiasm for projects while encouraging individual innovation and creativity.
• Solid project management skills to handle multiple projects and set/manage timelines with a high degree of urgency.
• Self-confidence and be decisive with excellent communication skills in both oral and written formats, as well as excellent listening, presentation and problem-solving skills.
• The ability to interface effectively with all levels and functions within the organization.
SUPERVISORY RESPONSIBILITIES:
• Manage internal and external resources
EDUCATION, EXPERIENCE, and TRAINING:
• 7-10 years of experience in regulatory affairs within the medical device industry, with a preference for ophthalmic experience and experience with implantable device.
• Bachelor or Master’s degree
• A "hands-on" style that inspires a strong, cohesive, team-focused work environment.
• Technical and continuous improvement experience with emphasis in the management and deployment of continuous product development for medical devices.
• A proven track record in therapy innovation, technology implementation and commercialization.
• A demonstrable track record of success in achieving and maintaining high quality standards.
• Training to be completed per the training plan for this position as maintained in the document control system
• The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis
CERTIFICATES, LICENSES, REGISTRATIONS:
• RAC optional
COMPUTER SKILLS:
• MS Office
