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 judgments, files regulatory reports, and ensures completeness and consistency of complaint documentation.

　　Roles & Responsibilities:

　　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 establish 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

　　Examine 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 Skills, Experience, Education, & Training:

　　Education - Minimum undergraduate degree in Nursing / RN or equivalent.

　　Experience - Minimum 5+ years of experience in medical device field (preferably surgical or critical care or operating room)

　　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

　　Demonstrate proven written and verbal communication skills

　　Excellent computer skills (Excel, Word, PowerPoint, database)

　　Efficient self-directed 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 autonomously

　　Prioritize numerous activities in a rapid paced environment

　　Contribute to team-oriented tasks

　　Exceptional 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

　　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.

　　Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

　　We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.