Sr. Manager, Complaint Handling
Abiomed, part of Johnson & Johnson MedTech is currently recruiting for a Sr Manager, Complaint Handling to be based in Danvers, MA in a hybrid capacity.
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients First!
The Sr. Manager, Complaints Handling role reports directly to the Director, Post Market Engineering and oversees all activities related to the complaint handling process. This role will provide direction to individuals who receive and investigate product complaints. They will follow established global regulations for complaint handling and prepare/assemble complaint information for regulatory inquiries. This person will provide support during inspections by regulatory bodies and ensure appropriate and timely global medical device reporting.
Principle Duties and Responsibilities:
- Oversee global complaint processing in compliance with FDA, Health Canada and EU MDR Quality System Regulations and country specific vigilance regulations.
- Manage Complaint Handling group including performance appraisals and development opportunities.
- Direct the timely in-flow of customer complaints and expedient processing and closure.
- Responsible for oversight of Global Adverse Event reporting program to ensure compliance.
- Responsible for oversight of the transmission of ROW incidents to the local contact for vigilance.
- Support additional information requests from global regulatory agencies.
- Define reports/dashboards to identify delinquency or backlog in all aspects of the complaint handling process.
- Identify process improvement opportunities to enhance surveillance and to increase efficiency.
- Collaborate with field-based teams and customer support center representatives to drive improvement of incoming complaint information.
- Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations.
- Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.
- BS degree with at least 8 years’ experience in medical devices with 3+ specifically related to post market surveillance.
- Minimum 3 years related Quality experience with at least 3 year managing direct reports. Experience with MDR/vigilance reporting globally preferred.
- Experience with FDA audits in both a front and backroom capacity is preferred.
- Strong knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 806, ISO 13485 & 14971, EU MDR.
- Demonstrated ability to implement and maintain accurate documentation consistent with applicable quality standards.
- Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability.
- Demonstrated successful project management.
- Strong leadership skills to engage the team, inspire high quality, timely work, and instill a spirit of continuous improvement.
- Must have excellent written and verbal communication skills and have a strong working knowledge of the development, application, and measurement of quality performance metrics.
- Ability to travel 10% domestically and internationally.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.