Regulatory Affairs Specialist

5 days ago


Jakarta, Indonesia Philips Full time

**Job Title**:
Regulatory Affairs Specialist

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 be working towards creating a better and fairer future for all.

**You are responsible for**
- Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
- Plan, generate, and coordinate regulatory submissions for product/solution licensing
- Maintain existing regulatory filings/ licenses, managing updates and related change control processes
- Assists with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy.
- Develop regulatory strategy, and if needed connect to regulatory SME’s and make regulatory plan
- Proactive stakeholder management with businesses/manufacturer
- Develops and facilitates regulatory submissions, for new products/solution, existing products/solutions
- Other regulatory projects as applicable.

**To succeed in this role, you’ll need a customer-first attitude and the following**
- Bachelor degree in related majors
- 1-2 years of experience in RA related role
- Proactive, good at communication skills, being able to deal with complex situations, high responsibilities and good at compliance mindset
- Proficient in English language

**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.



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