Regulatory and Quality Analyst
Buenos Aires, AR
hace 16 horas
source : DirectEmployers Association
  • null 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+ Establish DC support to authors and (local) process owners in defining and producing lean Quality System documents and records;
  • 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+ Works with a variety of diverse persons within the company such as Engineers, Scientists, Field Service & Application Engineers to facilitate reportable device events in accordance with written procedures and global reporting requirements Provides review of complaint to ensure all information needed for Reporting / MDRs is present;
  • 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+ English intermediate+ 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. Why should you join Philips?

    Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 2.

    5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

    Learn more by watching this video.To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog.

    Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions. #LI-PH1

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