Director, Complaint Vigilance

Intuvie; Natick (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Intuvie is seeking a Complaints Vigilance Director in Natick, MA to set strategic direction for complaint handling and ensure compliance with regulatory standards. This role requires a Bachelor's degree with 10+ years or a Master's with 7+ years of experience in medical devices. Major responsibilities include overseeing complaint investigations, regulatory submissions, and managing a vigilance team to ensure full compliance. The environment is supportive of individuals with disabilities.

Qualifications

• 10+ years of experience in medical device or 7+ years with a Master's degree.
• Extensive experience in complaint vigilance and MDR reporting.
• Skilled in interacting with government officials and conducting regulatory inspections.

Responsibilities

• Execute complaint vigilance in accordance with current standards and procedures.
• Oversee investigation and closure of product complaints.
• Prepare reports analyzing complaint trends and submit to Regulatory Agencies.

Skills

Complaint vigilance

MDR reporting

Regulatory inspections

Risk management

Education

Bachelor’s degree in science or engineering

Master’s degree

Job description

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.

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal business office environment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

*External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case-by-case basis.