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 identifiedEscalate Adverse Event or Incident reports to Level IV Analysts as identifiedEvaluate 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) groupEvaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirementsInterface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMACreate customer response letters upon requestProvide peer review and feedback of complaints and reportsParticipate in new hire training and continuous Regulatory Compliance training as requiredParticipate in process improvement activities to continuously improve process effectivenessExecute on projects as requiredPerform other duties as directedQualifications
Required Skills and Experience
Demonstrate strong written and verbal communication skillsStrong computer skills (Excel, Word, PowerPoint, database)Efficient independent worker with ability to focusAttention to detailDemonstrate cross functional communication skills in email and in personExcellent organizational and analytical skillsAbility to handle and manage workload independentlyPrioritize numerous activities in a rapid paced environmentContribute to team-oriented tasksStrong analytical skillsStrong interpersonal and decision-making skillsThe 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 documentationWorking 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.
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