In this role, you have the opportunity to
Act with the regulatory activities for Philips Healthcare Unit, supporting the strategies and using the appropriate tools to adapt the products in accordance with local legislation
You are responsible for
Effective (local) Business Process Ownership / Expert role for Document Control processes and tools in scope
ensure proper quality of the content of documentation and records
Establish and manage proper document review processes
Ensures availability / publishing of controlled documents
Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
Manage DHF / DMR / DHR
determine if further investigation is needed and track investigation to conclusion
Writes MDRs / MIR reports and submit to the necessary authorities
Monitors and improves tracking / control systems for medical device reporting
Support preparation response to address Competent Authority inquiries and provide follow-up
FSN management / follow up
To succeed in this role, you should have the following skills and experience
Experience analyzing large sets of data in a regulated industry.
Experience working within a Quality Management System.
Excellent teamwork skills including influencing and building rapport with internal customers and stakeholders.
Complete higher education or equivalent experience in the field
Excel Advanced is a plus
You are part of
This role is based in Buenos Aires, Argentina and will join to the Platino Cluster.
The candidate needs to live or relocated in Buenos Aires.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise.
We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
Furthermore, Philips University is available to all employees for learning and development opportunities.