Post Market Surveillance Specialist

Description

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:

The Post Market Surveillance Specialist supports regulatory compliance, patient safety, and continuous product improvement through accurate and timely documentation, assessment, investigation, reporting, and resolution of customer complaints. This role will support the Clinical Affairs and Product Surveillance Manager in various post-market product surveillance activities. Ability to work collaboratively in a fast-paced, cross-functional, systems-oriented environment is required.

Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Adhering to all RxSight procedures and quality system requirements when performing complaint handling activities.
• Intaking, processing, documenting, and tracking incoming clinical inquiries/complaints in a timely manner.
• Entering new complaint information into the complaint database/repository and reviewing new complaints to ensure all needed information is present.
• Communicating with field personnel and/or customers to gather information required for reportability determination and complaint investigations.
• Assessing complaints to determine regulatory reporting requirements in accordance with applicable FDA and international regulations.
• Preparing, submitting, and peer reviewing regulatory reports (FDA and Country/Regional Competent Authorities) within required regulatory timelines.
• Escalating high-severity events and complaints to management in accordance with RxSight procedures.
• Collaborating cross-functionally to ensure complete and accurate complaint investigations.
• Supporting CAPAs, HHEs, and other quality system processes, as required.
• Assisting with audits and audit requests related to complaint handling activities.
• Meeting complaint handling timelines, KPIs, and departmental performance metrics.
• Supporting the creation, update, and maintenance of procedures, work instructions, forms, reports, and letter templates to standardize complaint handling processes.
• Supporting the ad-hoc generation of complaint data and metrics, as needed.
• Maintaining a current working knowledge of evolving local, US, and international guidance and regulations for the medical device industry.
• Participating in special projects and initiatives, as assigned.
• Assisting with mentoring new team members.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong verbal and written communication skills.
• Excellent organizational and time management abilities.
• Ability to analyze technical data and articulate findings clearly.
• Ability to work effectively in a cross-functional, fast-paced environment.
• Knowledge of FDA regulations 21 CFR 820, 21 CFR 803, and 21 CFR 11.
• Knowledge of global post-market surveillance regulation for US, EU, Canada, and other applicable countries or regions.
• Proficiency with standard office software and technical documentation tools.

EDUCATION, EXPERIENCE, and TRAINING:

• Bachelor’s degree in biomedical engineering, nursing (BSN), certified ophthalmic professional (COA or COT), public health, other healthcare disciplines, or risk management preferred or a bachelor’s degree in another discipline with relevant experience.
• 2+ years of prior experience supporting complaint handling, reportability determination, medical device reporting, post-market activities, customer service, or related work in a highly regulated environment.
• MDR/Incident reporting experience preferred.
• Training to be completed per the training plan for this position.

Notice to Staffing Agencies and Search Firms:

RxSight does not accept unsolicited resumes or candidate submissions from staffing agencies or search firms for any employment opportunities. All agency engagements must be authorized in writing for a specific position by RxSight’s Talent Acquisition department. Any resumes or candidate information submitted without such specific engagement will be considered unsolicited and the property of RxSight. No fees will be paid in the event a candidate is hired under these circumstances.