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Intuvie

Director, Complaint Vigilance

Natick, MA · On-site

$180K - $190K/yr

GENERAL SUMMARY Sets strategic direction and ensures success of the Complaint Handling, MDR and post market reporting programs. Makes critical decisions for the Complaint Handling Unit (CHU). Primary ...

Intuvie

Director, Complaint Vigilance

Natick, MA · On-site

$180K - $190K/yr

GENERAL SUMMARY Sets strategic direction and ensures success of the Complaint Handling, MDR and post market reporting programs. Makes critical decisions for the Complaint Handling Unit (CHU). Primary ...

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What is the difference between Intuvie vs Medical Assistant?

AspectIntuvieMedical Assistant
Required CredentialsTypically requires specialized training or certification in specific medical proceduresHigh school diploma or equivalent; certification often preferred
Work EnvironmentClinics, hospitals, or specialized medical settingsDoctor's offices, clinics, hospitals
Employer & Industry UsageUsed in healthcare settings focusing on specific medical procedures or technologiesCommon in general healthcare practices and outpatient clinics
Common Search & ComparisonOften compared for roles involving patient care and technical skillsCompared for administrative and clinical support roles

Intuvie and Medical Assistant roles differ mainly in required credentials and work environment. Intuvie roles often involve specialized procedures, while Medical Assistants perform a broader range of clinical and administrative tasks. Both are vital in healthcare but serve different functions based on training and job scope.

What are the key skills and qualifications needed to thrive as an Intuitive (Intuvie), and why are they important?

Sorry, 'Intuvie' is not recognized as a real-world professional occupation, so I am unable to provide an answer for this job title.

What are Intuvie roles and what do they involve?

Intuvie is a company specializing in the development of medical devices, particularly those used for airway management and anesthesia. Roles at Intuvie typically involve working on the design, testing, manufacturing, and marketing of innovative airway devices. Employees may work in engineering, regulatory affairs, sales, clinical education, or customer support. The goal is to improve patient safety and outcomes during anesthesia and emergency procedures. Intuvie team members often collaborate with healthcare professionals to ensure their products meet clinical needs and regulatory standards.

What are some common challenges faced by Intuitive Surgical Sales Representatives, and how can new hires prepare for them?

Intuitive Surgical Sales Representatives often face the challenge of navigating complex hospital procurement processes and building relationships with multiple stakeholders, including surgeons, administrators, and purchasing departments. New hires should be prepared for a steep learning curve in understanding the technical aspects of robotic surgical systems and demonstrating their value to clinical teams. Success in this role requires excellent communication skills, persistence, and the ability to adapt to rapidly changing healthcare environments. Engaging in thorough product training and seeking mentorship from experienced colleagues can help new sales representatives overcome these challenges and excel in the role.
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Infographic showing various Intuvie job openings in the United States as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% Physical job distribution.

Director, Complaint Vigilance

Intuvie

Natick, MA • On-site

$180K - $190K/yr

Full-time

Posted 5 days ago

Job description

GENERAL SUMMARY

Sets strategic direction and ensures success of the Complaint Handling, MDR and post market reporting programs. Makes critical decisions for the Complaint Handling Unit (CHU). Primary interface to other department heads and upper management for complaint related topics and trending. Ensures complaint management procedures are optimized and that the vigilance team responds to and resolves complaints within a timely fashion while conforming to appropriate standards and procedures.


ESSENTIAL JOB FUNCTIONS

  • Execute complaint vigilance in conformance to current standards and procedures, using applicable system application tools in accordance with 21CFR820, 21CFR803, ISO 13485, and other regulations as required.
  • Oversee the initial assessment of complaints and assess risk and severity in accordance with product risk management files.
  • Oversee the receipt, evaluation, investigation, and closure of complaints, including device malfunctions.
  • Work with product/manufacturing/research & development/quality/medical affairs teams to ensure timely, accurate and complete investigations of product complaints and timely closures.
  • Prepare reports with analysis of complaint trends.
  • Oversee the assessment of complaints for MDR reportability to FDA.
  • Ensure initial and follow-up reports are submitted to Regulatory Agencies within required timelines.
  • Ensure complaints are classified correctly and that all supporting data are adequately documented and attached to the complaint file.
  • Ensure procedures meet current and evolving requirements.
  • Track and report metrics on process timeliness and effectiveness.
  • Represent the complaint handling unit in FDA inspections.


OTHER DUTIES AND RESPONSIBILITIES
  • Conduct annual complaint training for all employees including field sales on the requirements to report complaints in a timely manner.


PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
  • Bachelor’s degree in science or engineering with 10+ years of experience or Master’s degree with 7+ years of experience in medical device. Extensive experience and deep working knowledge of complaint vigilance and MDR reporting.
  • Experienced in regulatory inspections and skilled in interacting with government officials.
  • The Complaints Vigilance Director is responsible for managing the Vigilance Team. Responsible for team goal setting and performance assessments, as well as day-to-day people management.