Regulatory and Quality Analyst
Philips Lighting
Buenos Aires, Ciudad Autónoma de Buenos Aires, Argentina
hace 1 día

Job Description

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.

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