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Job TitleEMEA RA leaderJob Description
In this role, you have the opportunity to
Contribute with your regulatory skills to the innovation of products and services focusing on improving people’s health. You and your operations team in collaboration with regulatory/ Q&R team in the markets, have a strong interaction with Innovation teams on Regulatory Affairs (RA) matters.
You are part of the RA Safety, Compliance and Regulatory team and will be reporting to Regulatory Affairs Director, Premarket activities, International Markets.
You are responsible for
- Enabling all regulatory activities necessary to facilitate speed-to-market and to achieve all pre-market timelines and milestones
- Developing and implementing regional regulatory strategies and processes to support the timely registration of, new products, major changes and life cycle management
- Coordinate with Regulatory Affairs Director International premarket activities and lead premarket regulatory affairs specialists in the countries in the scope to ensure to ensure optimal, efficient and compliant registration
- Lead and drive regulatory premarket activities in accordance with local and international requirements to ensure Philips on time products registration or life cycle management in the markets in scope of responsibility
- Responsible for Regulatory pre-market activities, such as monitoring and analysis of new or updated local legislation and for assuring in-time registration in the local market (country)
- Create with innovation teams a regulatory plan and a labelling plan (when needed) to ensure consistency and guidance to the market introduction projects
- Ensure product compliance by executing the regulatory plan and reviewing all relevant compliance evidence
- Identify potential regulatory approval risks based on regulations, standards, country-specific issues or other unique characteristics
- Recommend strategies to the business on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive implementation and resolution
- Represent Philips in local or regional standard- committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
- Consult with product and solutions teams to ensure timely, effective and efficient transition to new requirements. Mentor and train others to effectively do the same
- Shares knowledge and is able to guide and mentor others about regulatory best practices and registration standards for regulatory approvals and post-market needs
You are a part of
the international management team of a regulatory team with members in international/ regional markets.
To succeed in this role, you should have the following skills and experience
- Master degree (Engineering or Medical / biomedical background)
- A minimum of 8 years working experience in Regulatory Affairs in International environment with at least 5 years in Regulatory Affairs in Emerging markets
- Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
- Experience in Project management within Regulatory Affairs
- FDA and EU MDD, CE marking experience is a plus
- RAPS certified is a plu
- Strong communicative and stakeholder management skills
- Fluent in English. Additional language is a plus
- Strong leadership skills
- Business partner and account manager capabilities
- Influencing and consulting skills
- Able to work in a constant changing environment
- Prepared to travel up to 20% regionally
- Act with Integrity and highly self-motivated
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
- 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.
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Embrace the unexpected
Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.
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