Manager Complaint HandlingMedical Device Reporting

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 10000 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. Convatecs 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

• 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 companys 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 companys 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 were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.

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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.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee

If you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site - Find Jobs. Thank you!