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Director, Regulatory Compliance

2 months ago

Aliso Viejo, United States RXSIGHT INC Full time
Job DescriptionJob DescriptionDescription:

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 Compliance will be responsible for post-market regulatory compliance through the review and assessment of product changes for impact on regulatory filings worldwide and annual reporting requirements globally. This position will also be responsible for U.S. and international regulatory submissions related to manufacturing and device changes, periodic product updates, license renewals as well as facility registrations globally.


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:

• Lead regulatory compliance activities, including:

o Evaluating product and manufacturing process changes for regulatory impact to US and OUS product registrations

o Reviewing and approving documentation such as validation test protocols and reports, and device labeling

• Support R&D, Manufacturing and Quality engineering with proper documentation of proposed device design and manufacturing process changes

• Prepare product change assessments to support US and OUS product approvals

• Compile materials necessary for timely license renewals, periodic updates and PMA supplements for manufacturing changes

• Maintain US/OUS device version approval matrix

• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.

• Establish and maintain system for tracking regulatory approvals internationally including device version approvals

• Maintain current knowledge of FDA and international regulations (CE, EUMDR, ISO, etc.), 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.

• Must work as an individual contributor and manage regulatory specialist(s) supporting change management

• Responsible for U.S. PMA Annual Report including device and manufacturing changes, non-clinical study summaries, and marketing history

• Monitor and provide management with impact of changes in the Regulatory environment

• Author and/or review regulatory procedures and update as necessary

• Participate in FDA & other notified body inspections, as needed

• Technical File maintenance for all products

• 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, ISO 10993), and international regulatory frameworks

• Act as PRRC

• In tandem with the Quality Department, participate in training of new employees on regulatory compliance activities

• Create budgets for regulatory department


Requirements:

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:


• A strong team player who works well in an informal, entrepreneurial environment.

• This role requires strong experience with post-market regulatory activities in the US, EU and other global markets

• 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.

• Ability to thrive in a fast-paced environment

• 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 regulatory specialist


EDUCATION, EXPERIENCE, and TRAINING:


• Bachelor or Master’s degree

• 7-10 years’ experience in the medical device industry with excellent regulatory or quality compliance experience (with a strong preference for expertise in leadership in optical devices and/or intraocular lenses).

• 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:


• None


COMPUTER SKILLS:


• MS Office