Lowongan kerja Regulatory Affairs Specialist

  • Full Time
  • Jakarta
  • Posted 11 months ago

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Lowongan Kerja
Lokasi Loker

Philips

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 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