Senior Medical Device Complaints & MDR Lead

Heartflowinc; Austin (TX); On-site; USD 75,000 - 100,000; Full time

Job summary

Heartflowinc is hiring for a Senior Complaint Specialist to oversee product complaint management and ensure compliance with global regulations. This role is critical for upholding safety standards and bridging customer feedback to quality improvement efforts. Candidates should have at least 5 years in the medical device industry and possess strong regulatory knowledge.

The estimated salary for this position ranges from $75,000 to $100,000, supplemented by a bonus. Heartflowinc values diversity and is committed to an inclusive work environment.

Qualifications

• 5+ years of relevant experience in the medical device industry, preferably with software medical device products (class II/III).

Responsibilities

• Manage product complaints and ensure regulatory compliance.
• Analyze complaint data for trends and risks.
• Prepare Medical Device Reporting (MDR) accurately.

Skills

Regulatory knowledge (21 CFR 820, 803, 806, EU MDR)

Proficient with Salesforce

Strong critical thinking skills

Excellent communication skills

Ability to work in a fast-paced environment

Education

Bachelor’s degree in Science, Engineering, or a related field

Tools

Salesforce

Tableau

MS Office

Google Workspace

Job description

Heartflowinc is hiring for a Senior Complaint Specialist to oversee product complaint management and ensure compliance with global regulations. This role is critical for upholding safety standards and bridging customer feedback to quality improvement efforts. Candidates should have at least 5 years in the medical device industry and possess strong regulatory knowledge.

The estimated salary for this position ranges from $75,000 to $100,000, supplemented by a bonus. Heartflowinc values diversity and is committed to an inclusive work environment.