Philips Q&R officer in Warszawa, Poland

Quality & Regulatory Officer Poland & Baltics - Maternity Cover.

This position intends to support QA/RA activities, acting on behalf of the QA/RA Manager in specific countries within the Region where necessary. Under the responsibility of the Q&R Officer, he/she manages Vigilance Reporting with Competent Authority for the assigned countries. He/she manages and/or supports product registrations (NPI or Renewals) to Competent Authorities. He/she monitors Mandatory FCO/FSN completion and ensure regulatory communication is timely executed. Ensure compliance with the applicable country regulations and PH standards & policies.Responsible for providing administrative support to Quality Management System and Regulatory Affairs. Key Areas of Responsibility Q&R Administration

  • Supports tracking of QMS related KPIs Customer feedback to ensure Compliance for the Region.

Post-Market Surveillance/ Vigilance (reportable complaints or other regulatory cases).

  • Supports any required filings for Medical Device and Safety Vigilance Reports within the defined time to Regulatory Agencies/ Competent Authority.

  • Performs communication internally with Philips BIU’s in regard to reported incidents.

  • Tracks status of reported incidents with Competent Authority ensuring all cases are closed by CA following adequate submission of objective evidence.

Product Registrations

  • Ensures country/ district Medical Product Approvals process and submissions when relevant (excluding 510K and CE Medical marking under BIU responsibility) – product notification and registration, if applicable, as per local countries requirement.

  • Supports Regional QA/RA Manager in preparing product registration documentation.

  • Coordinates with Competent Authorities and/ or Authorized Representative for product Registrations.

  • Tracks status of current and new product registrations.

Recall & Correction Management

  • Executes communication package localization. Proposes/executes Customer/Competent Authority communication.

  • Tracks product recalls for Mandatory field change orders (FCOs) to closure.

  • Informs Competent Authority and BIU's on MA FCO completion

Regulatory Affairs Management

  • Assists public relations efforts on regulatory issues, i.e. governmental efforts, Regulatory Warning letters and product recalls.

  • Supports the Region QA/RA Manager in representing Philips in country government & regulatory agencies to include medical device, environmental, nuclear, and other regulatory bodies.

  • Acts on behalf of Region QA/RA Manager as Philips regulatory representative at assigned regional/country trade or industry associations.

  • Keep aware of Regulatory requirements/ changes impacting the assigned country/ districts.

Quality Assurance Management

  • Administrative support to Quality Management system and projects

  • Provides specific support to the Q&R Manager with regards to the Quality Management System Deployment

  • CAPA management

  • Assures quality documentation workflow

  • Actively participates on preparations for external, corporate and in internal Philips quality audits

  • Is able to perform local internal quality audits when necessary

Tenders’ support

  • on request from sales support group and/ or distributor in case of a new tender

  • special requirements

Any other activities supporting Philips Healthcare as assigned by QA/RA Manager.Education & Experience

  • Awareness of Quality Management System and ISO 9001/ ISO 13485.

  • Awareness of Medical Device Regulatory Requirements – Product Registration & Reporting.

  • Awareness of at least one of the MD directives

  • Previous work experience in Medical Device or Pharmaceutical Industry.

  • Document / Data Management experience

  • Fluent in English, verbal and written

Competencies required

  • Good and verbal communication skills

  • Strong analytical skills and focus on details