Product Monitoring Manager

Summary

Join Calyxo, a medical device company, as their Product Monitoring Manager. You will lead a team investigating and resolving product complaints, ensuring timely processing and adverse event reporting. Collaborate with cross-functional teams to improve complaint processes, comply with regulations, and develop operational policies. Analyze data, present findings to senior management, and contribute to the company's quality management system. This role requires a Bachelor's degree in a related field, 5+ years of medical device experience, strong analytical and communication skills, and experience with complaint management. Calyxo offers a competitive salary, stock options, and an employee benefits package including 401(k), healthcare, and paid time off.

Requirements

• Bachelor's degree in Biomedical Engineering, Life Sciences, or related field; advanced degree preferred
• 5+ years of experience in medical device industry, with focus on post-market surveillance or related areas
• Strong knowledge of medical device regulations and quality management systems
• Excellent analytical and problem-solving skills
• Proficiency in data analysis tools and statistical methods
• Strong communication and presentation skills
• Ability to work effectively in a cross-functional team environment
• Bachelor of Science in Engineering, Technical, or Life Science discipline; or equivalent experience
• Minimum of 7 years experience in Complaint Management with a minimum of 5 years in the medical device industry preferred
• Excellent level of organizational skills and ability to work on several projects simultaneously with a high attention to detail
• Open and direct communication style and a vision for continuous improvement and excellence
• Compliance with relevant county, state, and Federal rules regarding vaccinations
• Must be able to lift 10 pounds and occasionally lift and carry up to 25 pounts, sit for up to 8 hours/day, including daily keyboard data entry

Responsibilities

• Plan, assign, and lead the team responsible for the investigation, analysis, resolution, and trending of complaints
• Ensure the timely processing of complaints and adverse event reporting
• Work with cross-functional groups such as Medical Affairs, Regulatory, Operations, Customer Service and R&D to perform all aspects of complaint investigations and complaint handling
• Manage and maintain product complaint processes with an emphasis on continuous improvement, system effectiveness, and efficiency to meet the current and future needs of the business
• Provide product development cycle feedback/data to reduce occurrence rates and enhance ongoing field training
• Assist in Quality System audits with various government agencies, private companies, and consultants (such as CA FDB, US FDA, etc.), and respond to any action promptly
• Maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities
• Partner with cross-functional departments on investigating product complaints and ensuring the timely completion and closure of complaint activities
• Ensure efficient compliance with all applicable regulations through the implementation of a robust complaint handling system and communication/reporting to regulatory authorities
• Lead the development of operational policies and procedures within the Complaint Management Program, and partner cross-functionally to ensure optimal processes exist to support upstream and downstream customer needs
• Participate in Management Review meetings and assist in gathering, preparing, analyzing and presenting data to executive management on the performance of the Quality Management System
• Develop Product Monitoring staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources
• Contribute to the development and maintenance of the company's quality management system
• Implement corrective and preventive actions (CAPAs) as needed
• Analyze complex datasets to extract meaningful insights on product performance and safety
• Develop and maintain dashboards and reports to communicate product monitoring results to stakeholders
• Present findings and recommendations to senior management and cross-functional teams
• Perform other duties as assigned

Preferred Qualifications

Experience with Class II or III sterile devices

Benefits

• Competitive salary of $149,000 - $159,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off
• Remote work
• Up to 10% travel