Quality & Regulatory Officer CEE
Aim of the job
This position supports Quality and Regulatory activities, acting on behalf of the QA/RA Manager / regulatory and Regulatory & Clinical Affairs Manager in specific countries within the Market and drives these activities in the rest of the CEE well as Quality and Regulatory Operations for as necessary.
Under the responsibility of the Q&R Officer, he/she supports and executes 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.
Supports the PQMS Specialist in where required in Quality Assurance activities.
Responsible for providing administrative support to Quality Management System and Regulatory Affairs.
Key Areas of Responsibility:
Quality Management System
To create Quality and Regulatory Awareness level as determined within the organization.
Supports maintenance of Quality Management System within the organization as applicable
Supports Customer feedback handling Complaint handling as necessary
Support the PQMS Specialist in the Audit Program execution for the organization.
Provides support as needed for monitoring and tracking QMS KPIs. Supports the PQMS Specialist and Q&R manager CEE in preparation of local Management Review.
Supports CAPA process as per instructions from PQMS Specialist/Q&R Manager CEE.
Plan, generate, and coordinate regulatory submissions for product/solution licensing for countries and products of responsibility
Supports testing activities for regulatory submissions when necessary
Review and approve product/solution labeling and product/solution-related marketing communications
Reviews of product regulatory documentation ensure these meet Market regulatory requirements
Maintains existing regulatory filings/ licenses and ensures necessary updates in timely manner
Supports applicable regulatory activities and processes as a back up.
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 for countries of responsibility.
Field Action Management: Manages recall responses, recall file documentation, recall file completion for countries of responsibility
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 for countries of responsibility
Establishes contacts within local competent authorities to support necessary regulatory activity submission for countries of responsibility
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, RED, 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 is an advantage
Fluent in English, verbal and written
Good verbal communication skills
Strong analytical skills and focus on details
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
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 .