Talent.com
Post Market Surveillance Analyst
Post Market Surveillance AnalystIntuitive Surgical, Inc. in • Sunnyvale, CA, United States
Post Market Surveillance Analyst

Post Market Surveillance Analyst

Intuitive Surgical, Inc. in • Sunnyvale, CA, United States
7 days ago
Job type
  • Full-time
Job description

Post Market Surveillance Analyst (Finance)

Company Description

At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

The Regulatory Post Market Surveillance Analyst captures complaints, investigates customer complaints, makes initial reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation. This position reports to a Regulatory Post Market Surveillance Supervisor or Manager.

Essential Job Duties

This position has responsibility and authority for :

  • Investigating complaints daily :

Complaint intake and triage for reportability

  • Perform the preliminary classification of complaints and escalate complaints that require additional review.
  • Perform Failure Analysis investigation review and escalate complaints that require additional review.
  • File Malfunction MDR Reports as identified
  • Escalate Adverse Event or Incident reports to Level IV Analysts as identified
  • Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
  • Approve final complaint file for closure after all applicable actions are completed.
  • Manage complaint workload to required backlog goals.
  • Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
  • Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered.
  • Escalate complaints with potential related product failures to the Post Market Investigation (PMI) group
  • Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements
  • Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
  • Create customer response letters upon request
  • Provide peer review and feedback of complaints and reports
  • Participate in new hire training and continuous Regulatory Compliance training as required
  • Participate in process improvement activities to continuously improve process effectiveness
  • Execute on projects as required
  • Perform other duties as directed
  • Qualifications

    Required Skills and Experience

  • Demonstrate strong written and verbal communication skills
  • Strong computer skills (Excel, Word, PowerPoint, database)
  • Efficient independent worker with ability to focus
  • Attention to detail
  • Demonstrate cross functional communication skills in email and in person
  • Excellent organizational and analytical skills
  • Ability to handle and manage workload independently
  • Prioritize numerous activities in a rapid paced environment
  • Contribute to team-oriented tasks
  • Strong analytical skills
  • Strong interpersonal and decision-making skills
  • The following experience is required for this position :

  • 4+ years of experience in medical device field, with experience in the following areas :
  • Working knowledge and understanding of Medical Device Complaint files and quality record documentation
  • Working knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MIR requirements, etc.)
  • Required Education and Training

  • Education : Undergraduate degree in engineering, life science, or equivalent.
  • Training / Competencies :

  • Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
  • Firm understanding of quality records requirements and how they apply to complaint files.
  • Familiarity with world-wide regulatory reporting requirements.
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
  • Working Conditions

  • This position requires the ability to complete most of the workday using a computer.
  • Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

    #J-18808-Ljbffr

    Create a job alert for this search

    Surveillance Analyst • Sunnyvale, CA, United States

    Related jobs
    Cybersecurity Analyst - Top Secret Clearance

    Cybersecurity Analyst - Top Secret Clearance

    VirtualVocations • Fremont, California, United States
    Full-time
    A company is looking for two Cybersecurity Analysts to provide advanced cybersecurity operations and compliance management support for a Department of Defense enterprise environment.Key Responsibil...Show more
    Last updated: 22 hours ago • Promoted • New!
    Sr. Sales Commission Analyst

    Sr. Sales Commission Analyst

    Supermicro • San Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show more
    Last updated: 30+ days ago • Promoted
    Sr. Analyst, FP&A

    Sr. Analyst, FP&A

    hackerone • San Francisco, CA, United States
    Full-time
    HackerOne is a global leader in offensive security solutions.Our HackerOne Platform combines AI with the ingenuity of the largest community of security researchers to find and fix security, privacy...Show more
    Last updated: 7 days ago • Promoted
    Remote Commercial Banking Analyst - AI Trainer

    Remote Commercial Banking Analyst - AI Trainer

    Data Annotation • Livermore, California
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the q...Show more
    Last updated: 30+ days ago • Promoted
    Vulnerability Analyst

    Vulnerability Analyst

    VirtualVocations • Fremont, California, United States
    Full-time
    A company is looking for a Vulnerability Analyst in the North Central region.Key Responsibilities Manage the vulnerability management lifecycle and assist in building and maintaining vulnerabilit...Show more
    Last updated: 18 days ago • Promoted
    Cornerstone Application Analyst

    Cornerstone Application Analyst

    VirtualVocations • Oakland, California, United States
    Full-time
    A company is looking for a Cornerstone Application Analyst to manage their Cornerstone Learning Management System.Key Responsibilities Manage the Cornerstone Learning Management System, including...Show more
    Last updated: 2 days ago • Promoted
    Senior Business Intelligence Analyst

    Senior Business Intelligence Analyst

    Waymo • Mountain View, CA, United States
    Full-time
    Waymo is an autonomous driving technology company with the mission to be the world's most trusted driver.Since its start as the Google Self-Driving Car Project in 2009, Waymo has focused on buildin...Show more
    Last updated: 30+ days ago • Promoted
    Mid-Level Business Intelligence Analyst

    Mid-Level Business Intelligence Analyst

    VirtualVocations • Santa Clara, California, United States
    Full-time
    A company is looking for a Mid-Level Business Intelligence Analyst to support a Department of Defense enterprise modernization effort. Key Responsibilities Serve as a liaison between USAF and Navy...Show more
    Last updated: 1 day ago • Promoted
    SOC Analyst

    SOC Analyst

    Fortinet • Sunnyvale, CA, United States
    Full-time
    Fortinet is looking for a Security Operations Centre (SOC) Analyst to be part of the FortiCloud SOC-as-a-Service team.This is a highly technical role, monitoring security events, identifying threat...Show more
    Last updated: 7 days ago • Promoted
    Sr. Cost Control Analyst

    Sr. Cost Control Analyst

    Supermicro • San Jose, CA, United States
    Full-time
    Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop / Big Data, Hyperscale, HPC and IoT / Embedded customers...Show more
    Last updated: 30+ days ago • Promoted
    Remote Senior Financial Analyst - AI Trainer

    Remote Senior Financial Analyst - AI Trainer

    Data Annotation • Morgan Hill, California
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the q...Show more
    Last updated: 30+ days ago • Promoted
    Remote Financial Analyst - AI Trainer

    Remote Financial Analyst - AI Trainer

    Data Annotation • Morgan Hill, California
    Remote
    Full-time +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the q...Show more
    Last updated: 30+ days ago • Promoted
    Travel Dosimetrist - $3,264 per week in Santa Cruz, CA

    Travel Dosimetrist - $3,264 per week in Santa Cruz, CA

    AlliedTravelCareers • Santa Cruz, CA, US
    Full-time
    AlliedTravelCareers is working with Tactstaff to find a qualified Dosimetrist in Santa Cruz, California, 95060!.TactStaff is seeking a dedicated Tech Dosimetrist for a rewarding opportunity located...Show more
    Last updated: 30+ days ago • Promoted
    Security Analyst with DoD Clearance

    Security Analyst with DoD Clearance

    VirtualVocations • Santa Clara, California, United States
    Full-time
    A company is looking for a Security Analyst-Mid Level.Key Responsibilities : Perform ongoing security analysis and compliance assessments under DoD Risk Management Framework (RMF) processes Utili...Show more
    Last updated: 10 hours ago • Promoted • New!
    Identity Security Analyst

    Identity Security Analyst

    VirtualVocations • Oakland, California, United States
    Full-time
    A company is looking for an Identity Security Analyst (Contract).Key Responsibilities Triage, analyze, and respond to identity hygiene issues and defects in ISPM platforms Coordinate with assura...Show more
    Last updated: 1 day ago • Promoted
    Cyber Intelligence Analyst

    Cyber Intelligence Analyst

    VirtualVocations • Hayward, California, United States
    Full-time
    A company is looking for a Cyber Intelligence Analyst to identify and mitigate information security threats.Key Responsibilities Identify, track, monitor, contain, and mitigate information securi...Show more
    Last updated: 1 day ago • Promoted
    Market Surveillance Analyst

    Market Surveillance Analyst

    VirtualVocations • Oakland, California, United States
    Full-time
    A company is looking for a Market Surveillance Analyst to join its Market Regulation team.Key Responsibilities Monitor trading activity to detect suspicious patterns and escalate concerns Conduc...Show more
    Last updated: 1 day ago • Promoted
    Senior Security Analyst

    Senior Security Analyst

    VirtualVocations • Santa Clara, California, United States
    Full-time
    Security Analyst, Falcon Complete (Hybrid).Key Responsibilities Exercise incident handling processes across Windows, Mac, and Linux platforms Perform malware analysis and develop processes for i...Show more
    Last updated: 30+ days ago • Promoted