Senior Regulatory Affairs Specialist

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 Vice President of Regulatory Affairs, the Senior Regulatory Affairs Specialist will be responsible for post-market regulatory compliance through the review and assessment of product changes for impact on regulatory filings worldwide to help ensure compliance with international product approvals. This position will also be responsible for submissions of periodic product updates, license renewals as well as facility registrations.

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.

• Assist with regulatory compliance activities, including:
  • Evaluate product and manufacturing process changes for regulatory impact to US and OUS product registrations
  • Reviewing and approving documentation such as validation test protocols and reports and device labeling
• In tandem with Quality, participate in training of new employees on regulatory compliance activities
• Support R&D, Manufacturing and Quality engineering with proper documentation of proposed device design and manufacturing process changes
• Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Prepare regulatory assessments to support US and OUS product approvals
• Compile materials necessary for timely license renewals, periodic updates and PMA supplements for manufacturing changes
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
• Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
• Maintain/submit facility registrations and device listings per global requirements
• Liaise with RxSight product labeling specialist on new and modified product labeling. Must have a working knowledge of the U.S. (pre-and post-market) and OUS labeling regulations and support 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.
• Develop understanding and maintain current knowledge of global regulatory requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Extensive knowledge of applicable government regulations.
• 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.

SUPERVISORY RESPONSIBILITIES:

• Manage internal and external resources

EDUCATION, EXPERIENCE, and TRAINING:

• Bachelor’s degree with over 5 years of experience in Regulatory Affairs within the medical device industry and at least 2 years of product change management experience.
• 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:

• None

COMPUTER SKILLS:

• Word, Excel, PowerPoint