Q&R Specialist CEE
Job TitleQ&R Specialist CEE
- Responsible for providing administrative support to Quality Management System and Regulatory Affairs.
- This position intends to support Quality and Regulatory activities, acting on behalf of the QA/RA Manager in specific countries within the Market and coordinate these activities in the rest of the CEE well as Quality and Regulatory Operations as necessary.
- Under the responsibility of the Q&R Specialist, he/she manages and/or supports product certifications/ approbations with Competent Authorities, communicates with Business, marketing and innovation sites on product introduction plan in CEE.
- Ensure compliance with the applicable country regulations and Philips standards & policies.
Key Areas of responsibility:
Quality Management System
- To create Quality and Regulatory Awareness level as determined within the organization.
- Establish and implement a Simplified Quality System within the organization; establish an effective Management Review process, including routine reporting.
- Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction. Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. Includes Complaint handling
- Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
- Directs the Audit Program for the organization.
- Interacts with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation.
- Monitors and tracks QMS KPls. Helps prepare for local Management Review.
- Supports initiation and follow up of CAPAs to address process failures/ audit non-conformities and improvements.
- Review development quality reports and plans to ensure that the information required for submissions is adequate
- Plan, generate, and coordinate regulatory submissions for product/solution licensing
- Coordinate testing required to support regulatory submissions (just in some countries)
- Review and approve product/solution labeling and product/solution-related marketing communications
- Maintain existing regulatory filings/ licenses, managing updates and related change control processes
Post Market Surveillance & Vigilance Reporting
- AE Reporting: Communicate MDR/MIR to the customer and Competent Authorities and or other regulatory agency as required by country/Market.
- Field Action Management: Manages recall responses, recall file documentation, recall file completion
- Regulatory Intelligence gathering
- Works closely with local (and assigned geography) Competent
- Authorities to understand implementation of Medical Device Regulations (or any other regulations) impacting Philips Product portfolio.
- Establishes contacts within local competent authorities to support necessary regulatory activity submission.
- Any other activities supporting Philips Healthcare as assigned by QA/RA Manager.
Education & Experience:
- Awareness of Quality Management System and ISO 9001/ ISO 13485.
- Experience of Medical Device Regulatory Requirements — Product Registration & Reporting.
- Good Knowledge to EU Directives to MD, R&TTE, ROHS, IVD, Food Basic Knowledge about CE-Marking process and applicable IEC Test standards
- Previous work experience in Medical Device or Pharmaceutical Industry, preferably in environment of larger, multinational organization
- Awareness of Consumer and Cosmetic products.
- Document / Data Management experience Fluent in English, verbal and written
- Good verbal communication skills
- Strong analytical skills and focus on details
- Customer Centric
- Good cooperation with partners in- and outside the Q&R organization as well as outside Philips (e.g. Business Managers, Philips Manufacturers, Legal dpt., Service, Sales, Distributors, Authorities)
- Proactive way of working
- Team Player and ready to share knowledge
- Able to work independently and set own targets
- Find ways through a big and complex organization and able to build up an own Network
- Understand the counterpart and find solutions within given limits
- Understand and follow given processes (Philips and outside) Flexible, positive, open, trustable
- Must be willing to put up with quite significant amount of administration
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 3 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.
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