Job Title Regulatory Affairs Business Manager Job Description In this position the regulatory affairs specialist will be responsible for leading high profile regulatory planning projects for the international markets and for medical devices and non medical devices business. The regulatory affairs specialist is a strategic partner for the business groups and local countries representatives. The activities will focus on building a robust end to end regulatory center of excellence and operational mechanism in the aim of speed time to markets with full end to end visibility to ensure proper opportunities are captured and to work on the identified areas for improvements. We are looking for a decision maker, an influencer and gatekeeper to support the business units and countries related stakeholders in the aim of speed time to markets. You are responsible for: Regulatory ownership of medical devices, being the primary point of contact as process owner and planning of activities for EU and non-EU countries in international markets. On time involvement in the business units and sites projects and value proposition creation Create assessments of medical device classifications for applicable markets globally Create regulatory strategy plan for new products introduction in coordination with local markets and sites stakeholders. Create a proper end to end process In regulatory as a center of excellence you are a part of a dynamic and divers team of highly specialized professionals with a common goal. You are a part of The regulatory affairs International markets team ( EU and non EU countries). The team you will be working in, is a high-performance, culturally diverse, and very dynamic team. It consists of 14 people working in the areas, divided over Israel, America and the Netherlands. To succeed in this role, you should have the following skills and experience 5 years of experience in medical device regulations, in building center of excellence or processes related to regulatory Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), and knowledge about other non-EU countries regulations Proven successful track record in creating a LEAN process for medical devices or pharmaceuticals Familiar with quality management system and ISO 13485 would be a plus Strong personality being able to take position and guide a project team with critical strategic thinking. Knowledge of different standards for household and medical devices (e.g. electrical standards) is a plus Knowledge on software development could be a plus Microsoft and database skills required In return, we offer you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences: 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 How we work at Philips Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. 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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. LI-EU