Clinical Affairs Specialist job vacancy in Rxsight, Inc, (Aliso Viejo, CA 92656)

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Job Details
Company Name : Rxsight, Inc
Company Location : Aliso Viejo, CA 92656
Job Position : Clinical Affairs Specialist
Job Category : Jobs in California

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.
OVERVIEW:
Clinical Affairs Specialist is responsible for supporting clinical inquiries and post-market surveillance reports received from users of RxSight’s Light Adjustable Lens and supporting RxSight clinical studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

Tracking, categorizing and follow up of complaint/MDR reporting (if applicable) for clinical inquires received

Develop clinical inquiry management system to track and catalogue current inquiries and investigative findings for systematic future retrieval and guidance.

Working with RA and QA to ensure that any Product Investigation documentation is completed per standard operating procedures.

Assist with protocol development, informed consent form development, establishment of clinical methodology, and type/use of clinical equipment for US and OUS post-market clinical studies

Participate in study start up activities for pre-market and post-market clinical studies

Assist with developing reporting metrics, tables and line listings for regulatory submissions and peer-reviewed publications

Required Knowledge, Skills and Abilities:

Must possess excellent communication skills so as to be able to effectively convey messages to both study team members and other external persons like vendors and external consultants

Ability to pay keen attention to detail at all times

Demonstrate ability to liaise with individuals of all levels, to include surgeons, clinical staff and facility administrators.

Clinical experience and knowledge of the cataract patient diagnostic and evaluative process at the clinic level.

Proven communication skills with demonstrable past experience.

EDUCATION, EXPERIENCE, and TRAINING:

Oophthalmic professional,two to four years related experience and/or training; or equivalent combination of education and experience.

Knowledge of ophthalmology

Candidate must be willing to work in Aliso Viejo office

Able to manage multiple projects simultaneously

Must enjoy working in a fast-paced startup environment with proven ability to be flexible and adaptable within a changing dynamic environment.

CERTIFICATES, LICENSES, REGISTRATIONS:
Certified Ophthalmic Technician desirable, but not required.
COMPUTER SKILLS:
MS Office Products