Remote Complaint Analytics Manager - MedTech

Calyxo; United States; Remote; USD 145,000 - 155,000; Full time

Benefits offered by this job

Stock options

Healthcare insurance

Paid vacation

401(k) plan

Job summary

Calyxo, Inc. in Pleasanton, California, is seeking a Complaint Analyst Manager to lead the team responsible for intake, follow-ups, investigation, and trending of complaints, including adverse event reporting.

You will collaborate with Investigators, Medical Affairs, Regulatory, Operations, Customer Service and R&D to ensure timely processing and regulatory compliance in post-market activities.

Qualifications

• Bachelor's degree in engineering, technical or life sciences or equivalent experience.
• Minimum 15 years in the medical device industry.
• Remote work within California with up to 10% travel.
• Strong knowledge of FDA CFR parts 820/803 and ISO 13485.

Responsibilities

• Lead the Complaint Monitoring team through intake, investigation and trending.
• Coordinate with Investigators, Medical Affairs, Regulatory, QA and R&D to handle complaints.
• Prepare metrics and reports on complaint handling and MDR activities.

Skills

Leadership

Regulatory knowledge

Communication skills

Problem solving

Process improvement

Education

Bachelor of Science in Engineering/Technical or Life Science

Tools

Quality Management System (QMS)

FDA 21 CFR 820.198/803

ISO 13485 / ISO/EN standards

Job description

Calyxo, Inc. in Pleasanton, California, is seeking a Complaint Analyst Manager to lead the team responsible for intake, follow-ups, investigation, and trending of complaints, including adverse event reporting.

You will collaborate with Investigators, Medical Affairs, Regulatory, Operations, Customer Service and R&D to ensure timely processing and regulatory compliance in post-market activities.