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.
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
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
on request from sales support group and/ or distributor in case of a new tender
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
Good and verbal communication skills
Strong analytical skills and focus on details