Manager - Complaint Handling/Medical Device Reporting

ConvaTec Inc; City Of London; Remote; GBP 50,000 - 70,000; Full time

Job summary

A global medical products company is seeking a Complaint Evaluation Manager to lead the team responsible for medical device reporting and complaint investigations. This remote role requires a Bachelor's degree in Science or Engineering and experience in medical devices or clinical care. The ideal candidate will oversee complaint handling processes and ensure timely submissions of Medical Device Reports (MDRs) to regulatory agencies.

Qualifications

• Experience in medical device, biomedical engineering, or clinical care.
• Bachelor's degree in Science, Engineering, or equivalent.
• Advanced knowledge of operational procedures and tools.

Responsibilities

• Process, investigate, and monitor trending of product defect complaints.
• Align with Medical Safety on adverse events during complaint investigations.
• Monitor complaint activity and suggest modifications to processes.
• Provide technical expertise for complaint processing systems.
• Ensure all product complaint investigations are concluded properly.
• Track effectiveness of corrective actions for product complaints.

Skills

Medical device experience

Biomedical engineering knowledge

Clinical care

Technical expertise in complaint processing

Education

Bachelor's degree in Science or Engineering

Job description

Job Overview

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. This newly created remote position is focused on complaint evaluation, medical device reporting, vigilance submissions, and team leadership within the Infusion Care sector. The role will lead the team responsible for medical device and vigilance reporting, reviewing complaint investigations, and ensuring the prompt submission of Medical Device Reports (MDRs) in collaboration with Medical Safety, Regulatory Affairs, Manufacturing, and other relevant departments. The role involves performing quality checks of complaints and reports, as well as ensuring all required reports related to adverse event reporting are submitted on time to regulatory agencies, National Competent Authorities, and Notified Bodies.

Responsibilities

• Process, investigate, and monitor trending and reporting of product defect complaints, serving as primary contact.
• Align 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 ensuring compliance with regulatory agencies reporting requirements.
• Monitor complaint activity and provide suggestions to appropriate company authorities to modify existing manufacturing or packaging process and/or customer training processes, based upon pattern and related analyses.
• Maintain unified product defect investigation operating procedures. Provide technical expertise to optimize complaint processing systems.
• Maintain and monitor systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure.
• Track and evaluate effectiveness of corrective actions associated with product complaints and adverse events.

Qualifications

• Experience in medical device, biomedical engineering or clinical care.
• Bachelor's degree in Science, Engineering or an equivalent qualification.
• Requires advanced knowledge of operational procedures and tools obtained through extensive work experience and may require vocational or technical education.
• Responsible for working under limited supervision for non-routine situations and may be responsible for leading daily operations.

Company Overview

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