Manager - Complaint Handling/Medical Device Reporting
Convatec
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
About Convatec
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec's revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com
About the role
Manages the team responsible for the review and evaluation of complaints, conducting medical evaluations for the purpose of evaluation and regulatory reporting determination of product complaints. Manages the team providing final review of complaints and initiates complaint closure. Position includes oversight of timely submission of initial and supplemental medical device reports (MDRs) to FDA as part of post market compliance activities within the complaint handling system.
Responsibilities
Processes, investigates, and monitors trending and reporting of product defect complaints, serving as primary contact.
Aligns with Medical Safety and/or R&D on adverse events while addressing and expediting product complaints under the company's complaint policy and procedures, and ensures compliance with regulatory agencies reporting requirements.
Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing manufacturing or packaging process and/or customer training processes, based upon pattern and related analyses.
Maintains unified product defect investigation operating procedures. Provides technical expertise to optimize complaint processing systems.
Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure.
Tracks and evaluates effectiveness of corrective actions associated with product complaints and adverse events.
Requirements
Requires advanced knowledge of operational procedures and tools obtained through extensive work experience and may require vocational or technical education. Responsibilities may include:
Working under limited supervision for non-routine situations and may be responsible for leading daily operations.
Training, delegating and reviewing the work of lower level employees.
Problems are typically difficult and non-routine but not complex.
Ready to join us?
At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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