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
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
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.
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
1. Processes, investigates, and monitors trending and reporting of product defect complaints, serving as primary contact.
2. 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.
3. 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.
4. Maintains unified product defect investigation operating procedures. Provides technical expertise to optimize complaint processing systems.
5. Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure.
6. Tracks and evaluates effectiveness of corrective actions associated with product complaints and adverse events.
Requirements
7. Experience in medical device, biomedical engineering or clinical care
8. Bachelor's degree in Science, Engineering or an equivalent qualification
9. Requires advanced knowledge of operational procedures and tools obtained through extensive work experience and may require vocational or technical education. Responsibilities may include:
10. Working under limited supervision for non-routine situations and may be responsible for leading daily operations.
11. Training, delegating and reviewing the work of lower level employees.
12. Problems are typically difficult and non-routine but not complex.
Our transformation will change your career. For good. You’ll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you’ll be supported to bring them to life. There’ll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.