Specjalista ds. Jakości i Regulacji
Location: Warsaw
Organization: Healthcare Quality & Regulatory
Job ID no: 136618
Philips Healthcare
At Philips, we try to simplify healthcare through combining our unique clinical expertise with human insights to develop innovations that ultimately help to improve the quality of people’s lives. Philips is dedicated to making an impact wherever care happens, within the hospital - critical care, emergency care and surgery – and, as importantly, in the home.
As Quality & Regulatory (Q&R) Officer for Poland and Baltics you will be responsible for managing Vigilance Reporting with Competent Authority for the assigned countries. You will manage and/or supports product registrations to Competent Authorities.
Responsibilities:
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Post-Market Surveillance – Vigilance: support any required filings for Medical Device and Safety Vigilance Reports within the defined time to Regulatory Agencies/ Competent Authority
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Product Registrations: ensure country/ district Medical Product Approvals process and submissions when relevant - product notification and registration, if applicable, as per local countries requirement
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Recall & Correction Management: execute communication package localization. Propose/execute Customer/Competent Authority communication
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Regulatory Affairs Management: assist public relations efforts on regulatory issues, i.e. governmental efforts, Regulatory Warning letters and product recalls
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Quality Assurance Management: administrative support to Quality Management system and project
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Tenders’ support: on request from sales support group and/or distributor in case of a new tender
Requirements:
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University degree
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Minimum 2 years of experience in Regulatory/ Quality position working with ISO 9001 and ISO 13485 quality standards
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Awareness of Medical Device Regulatory Requirements – Product Registration & Reporting
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Awareness of at least one of the MD directives
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Previous work experience in Medical Device or Pharmaceutical Industry
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Fluent in English, verbal and written
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Document / Data Management experience
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Good and verbal communication skills
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Strong analytical skills and focuson details
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Superior problem-solving and trouble-shooting skills
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Strong teamwork skills
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Ability to work under a minimum of supervision