17 days old

Post Market Surveillance Adverse Event Analyst

Intuitive Surgical, Inc.
Sunnyvale, CA 94086
  • Job Code
    JOB907
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
Primary Function of Position:

The Regulatory Post Market Surveillance Adverse Event Analyst investigates customer complaints related to injury / adverse event / or death cases and makes reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation.

Roles and Responsibilities:

This position has responsibility and authority for:

  • Investigating serious injury / adverse event and death complaints daily:
    • Perform the preliminary classification of complaints including reportability triage and decision making
    • Conduct complaint investigations including following up with surgeons and other health care professionals
    • Escalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.
    • Review product analysis investigation and determine cause / contribution of event to device
    • Draft and file medical device and Vigilance Reports
    • Evaluate documentation for completeness and consistency
    • Approve final complaint file for closure after all applicable actions are completed
    • Manage complaint workload to required timeliness and goals
  • Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events
  • Adherence to standard operating procedures and guidance documents across the organization for reporting, investigation and compliance related to post market requirements
  • Recognize and escalate trends and alert limits or process triggers of safety concerns to defined escalation path to communicate these concerns.
  • Provide the risk management team required data to support and incorporate new failure modes into risk management files
  • Collaborate with the Medical Safety Office to support monitoring activities and ensure timely escalations.
  • Ensure compliance to post market surveillance processes for regulatory database searches, literature reviews, surveys, and other proactive surveillance
  • Assess product relationship to reported complaints to root cause
  • Align to standard regulatory reporting assessment criteria
  • Provide input to clinical conclusion to be included in the complaint file and regulatory reports
  • Complete responses for Regulatory Agency Requests for additional information
  • Represent Post Market Surveillance at selected cross functional meetings
  • Analyze complaint data to identify trends, issues or systemic discrepancies
  • Provide monthly ,daily, weekly reporting of key metrics and action plans
  • Drive the progress of complaints throughout the complaint lifecycle to ensure proper documentation and timely closure of each complaint
  • Participate in internal and external audits
  • Develop and maintain product knowledge of existing and new products
  • Perform reportability determinations in conjunction with medical safety officer, as necessary
  • Maintain awareness of new or revised regulations and/or guidelines
  • 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
Level III Skill/Job Requirements:

Education - Undergraduate degree in engineering, life science, or equivalent

Experience - 5+ years of experience in medical device field, with experience in the following areas:

Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File management

Global regulatory medical device requirements for EU, MDSAP countries, and other related requirements

Skills: The following skills are required for this position:

  • 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.
  • Competency / Training : The following competencies are essential for this position:
  • Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements including good documentation practices and quality system elements.
  • 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.

Additional Information
All your information will be kept confidential according to EEO guidelines.

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Employment 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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Shift : Day

Travel : None





Posted: 2022-08-02 Expires: 2022-08-31
Sponsored by:
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Post Market Surveillance Adverse Event Analyst

Intuitive Surgical, Inc.
Sunnyvale, CA 94086

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