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