Philips Q&R Specialist Poland & Baltics in Warszawa, Poland
see attached Job Description
In this role, you have the opportunity to:
- Guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for:
Supporting Quality Assurance (QA)/Regulatory Affairs (RA) activities, acting on behalf of the QA/RA Manager in Poland and Baltics
Supporting the track of QMS related KPIs Customer feedback to ensure Compliance for the Region
Supporting any required filings for Medical Device and Safety Vigilance Activities within the defined time to Regulatory Agencies/ Competent Authority (ensuring country/district Medical Product Approvals process and submissions when relevant – product notification and registration, if applicable, as per local countries requirement; tracking product recalls for Mandatory field change orders (FCOs) to closure)
Assisting public relations efforts on regulatory issues, i.e. governmental efforts, Regulatory Warning letters and product recalls.
Supporting the Region QA/RA Manager in representing Philips in country government & regulatory agencies to include medical device, environmental, nuclear and other regulatory bodies.
Providing administrative support to Quality Management system and projects
Assuring quality documentation workflow
Actively participating on preparations for external, corporate and in internal Philips quality audits
Offering assistance on request from sales support group and/or distributor in case of a new tender
You are part of the Q&R CEE team and will be based in our office in Warsaw
To succeed in this role, you should have the following skills and experience:
Bachelor’s Degree in Science or similar discipline.
Awareness of Quality Management System and ISO 9001/ ISO 13485.
Awareness of Medical Device Regulatory Requirements – Product Registration & Reporting.
Previous working experience in Medical Devices or Pharmaceutical Industry.
Fluent in Polish and English, verbal and written
Strong analytical skills and focus on details
Very good relationship skills (manage stakeholders/be an ambassador of Q&R)
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based 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.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .