Updated 2 days ago

Regulatory Post Market Surveillance Specialist

Sunnyvale, CA 94087
Full-time

At Intuitive, 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. Our mission is our guiding force; our culture is the DNA that makes us unique.  

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare’s complex challenges. 

We believe a great idea can come from anywhere—inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse 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 strive to 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 help to advance the world of minimally invasive care. 

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

Skills and Job Requirements:

Minimum Education - Undergraduate degree in engineering, life science, or equivalent
Minimum 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
  • General technical and or clinical medical device knowledge
  • Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)

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.

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 : Shift 1 - Day

Travel : No

Travel Requirements: No Shift: Shift 1 - Day
Posting ID: 632420568Posted: 2021-06-22Job Title: Regulatory Post Market Surveillance