In this role, you have the opportunity to
be responsible for the regulatory strategy bringing products to the market, coordinate and prepare of regulatory plans and document packages for regulatory submissions (Global, FDA, EU, Asia, etc.).
The Regulatory Affairs manager also provides strategic input during the product creation process and helps to develop the department’s overall regulatory strategy plan. At Philips Digital & Computational Pathology, the RA Manager cooperates closely with Product Development, Medical / Clinical Affairs and Marketing and Sales. A software product development expert with experience in Regulatory Affairs in the (IVD) Medical Device environment is very welcome.
You are responsible for
Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy
Reviewing and creating the content of the (pre)submissions: Assuring regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for product life cycle teams, provides guidance to the team on risk assessment and required actions to create objective evidence that meets regulatory requirements
Planning, coordination and preparation of document packages for regulatory submissions to the US, EU, China, Asia [e.g. 510(k) Pre-market Notifications, Product Reports/Supplements, CE Marking, EU IVD, Health Canada]
Coordinating and preparing (pre)submissions and participate in meetings with FDA and other external regulatory agencies like SFDA and PMDA
Participating in FDA inspections and Notified Body audits.
Creating an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
You are a part of
a global business that leads the change to digital and computational pathology. Philips IntelliSite Pathology Solution has an in vitro diagnostic device status in more than 50 countries e.g. in Europe, USA, Middle East and Asia. Philips IntelliSite Pathology Solution is the first digital pathology solution available for primary diagnosis in the United States of America and Japan. With a full portfolio of solutions for computational pathology, education, research and collaboration, Philips supports the transformational change of digital pathology to empower decision-making and precision diagnostics.
To succeed in this role, you should have the following skills and experience
Bachelors or Master in a technical field
Minimum of 7 years relevant working experience in (IVD) medical device related to regulatory strategy development supporting submissions and product market introductions
Experienced in leading regulatory affairs projects to create/ensure required content of documentation intended for regulatory submissions
Excellent working knowledge of global (IVD) medical device regulations
Ideally regulatory affairs related experience of software medical devices on cloud/IT platform
Experience with the global registration of standalone software in medical devices and the positioning of software in combination with other medical devices.
Excellent verbal and written communication skills
Good communicator and team player who is able to work in a flexible and goal oriented environment
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.
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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. 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 on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .