Requirements: English
Company: Medacta Italia
Region: Mendrisio , Ticino
The Materiovigilance & Complaints Specialist will be responsible for monitoring and managing adverse events and complaints related to the companys orthopedic products. This role involves ensuring the timely investigation of complaints, reporting to regulatory authorities, and supporting the post-market surveillance process. The specialist will work closely with cross-functional teams to ensure compliance with global regulatory standards.
The candidate will be responsible for managing the following activities:
- Complaint handling: Receive and process complaints related to orthopedic products, ensuring they are properly documented and investigated in a timely manner;
- Adverse event reporting: Monitor adverse events related to medical devices and prepare reports for submission to regulatory authorities, in compliance with MDR, FDA, and other relevant regulations;
- Root cause analysis: Support investigations into complaints and adverse events by conducting root cause analysis and working with quality and R&D teams to implement corrective actions;
- Post-market surveillance: Assist in the execution of post-market surveillance activities, including data collection and analysis of product performance in the field;
- Regulatory compliance: Ensure compliance with global regulatory requirements for materiovigilance and complaints, including the preparation of necessary documentation for audits and inspections;
- Cross-functional collaboration: Collaborate with quality, regulatory, and R&D teams to address and resolve complaints, ensuring continuous improvement of product safety and performance;
- Data analysis: Analyze trends and patterns in complaints and adverse events, providing insights to the Global Head of Materiovigilance & Complaints and other stakeholders;
- Process improvement: Contribute to the development and improvement of the companys materiovigilance and complaints handling processes;
- Training & awareness: Support the training of internal teams on materiovigilance processes and regulatory requirements, promoting a culture of compliance and safety.
Hard Skills
The resource should also have the following skills:
- Degree in a technical field (bioengineering, biotechnology, etc.)
- Excellent knowledge of English
- Basic knowledge of other languages (especially French, German is a plus)
- Good knowledge of main computer packages (MS Office, etc.) and advanced use of Excel
- Basic knowledge in the use of Python and Minitab
Soft Skills
- Strong attention to detail
- Ability to concentrate on documentation for long periods
- Effective team player
- Understanding of technical processes, mechanics, and software systems
What We Offer
- Permanent contract
- Flexible working hours
- Carpooling organized by Medacta
- Incentives for mobility by public transport
- Advantageous conventions
- Growth opportunity in a continuously improving and expanding environment
- Annual salary review based on performance and professional development
- Continuous training
Medacta International is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
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