Director, Complaint Vigilance & MDR Strategy

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

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.