Regulatory Affairs Specialist (IN) ORU 474053

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better.

Looking at the challenges the world is facing today, Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll work towards creating a better and fairer future for all.

You will be working for the Magnetic Resonance Regulatory Affairs Team for a truly international team.

You are responsible for;

• Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory requirements for CE marked/FDA cleared devices in the countries of distribution in order to ensure that our products comply with the regulations

  
  

• Good Understanding of UDI/ EUDAMED and GTINs

  
  

• Expanding your regulatory knowledge of the geographies you are responsible for, liaising with local Philips Entities, Distributors, local Trade Associations and other sources of Regulatory Intelligence.

  
  

• Identifying Process optimization to strengthen the International Regulatory Affairs.

  
  

• Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.

  
  

• Following Quality System procedures to ensure compliance with all other applicable regulations.

  
  

• Maintaining proficiency in broad, regional regulatory requirements.

  
  
  

• Maintenance of regulatory and product data in cases of regulatory changes or product updates;

  
  

• Global Item Creation/ Item Setup in the PIM system;

  
  

• Local Item Creation / Item Setup in the ERP with focus on local requirements.

You are a part of

You will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.

To succeed in this role, you’ll need a customer-first attitude and the following.

• Bachelor's/master’s degree in engineering/Pharmacy/ Science preferred.

  
  

• 7+ years of medical device experience with a bachelor’s degree and work experience in Regulatory Affairs, or three years of medical device experience with a Master’s degree and work experience in Regulatory Affairs.

  
  

• Excellent communication, both written and verbal, as well as experience with communication and presentations to leadership.

  
  

• Demonstrated experience in multiple types of International regulatory submissions.

  
  

• Must have a working knowledge of FDA, ISO 13485, EU MDR, and other applicable regional regulations.

  
  

• Ability to make timely decisions, sometimes with incomplete information and under tight deadlines.

Knowledge of PC hardware/software, documentation and archives (Proficiency in Microsoft Office Suite, particularly Word and Excel)

In return, we offer you an opportunity to serve a bigger purpose. At Philips, our mission to improve the lives of 2.5 billion people per year by 2030, and every day, we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients drive us. We enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalised development planning programs. Our business provides unique opportunities to develop and deliver meaningful solutions in the healthcare space. This new position is a unique opportunity to shape the next-generation solutions we are developing.

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.