Post Market Surveillance Specialist

Primary Function of Position:
 The Regulatory Post Market Surveillance Specialist investigates customer complaints makes an initial reporting decision provides failure analysis letters and ensures completeness and consistency of complaint and related documentation.

Roles and Responsibilities:
This position has responsibility and authority for:

• Investigating complaints daily:
  • 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 to the Post Market Investigation (PMI) group as required
• 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
• 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 and Job Requirements:

Education:

• Undergraduate degree in engineering life science or equivalent

Experience:

 2 years of experience in medical device field with experience or exposure in the following areas:

•  Knowledge and understanding with Medical Device Complaint files and quality record documentation
• Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements EU MDD requirements etc.)
• General technical and or clinical medical device knowledge

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:

• General understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements.
• General understanding of quality records requirements and how they apply to complaint files.
• 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 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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

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 base compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time