Regulatory Post Market Surveillance Specialist

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 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

Qualifications

Skills and Job Requirements:

Education - 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

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Shift: Day