Regulatory Affairs Specialist

4 weeks ago

Singapore Philips Full time
Job TitleRegulatory Affairs SpecialistJob Description

Regulatory Affairs Specialist – Singapore and Emerging Markets

In this role, you have the opportunity to

Utilize your expertise and knowledge of regulatory in developing and following–up closely the regulatory strategy and deployment within Singapore and Emerging Market

You will be part of Singapore Regulatory team and be the interface mainly of Distributors and manufacturers.

This role will be responsible for supporting of a variety of regulatory activities in Singapore and Emerging Market.

Responsibilities to ensure regulatory information management system and proper regulatory strategy and deployment for Business and marketing team and the required packages and deliverables. Capability to translate the regulatory strategy and deployment into patients needs.

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.

You are a part of:

You are part of Singapore Regulatory team. Reporting line of this position is to ASEAN RA manager. You will have exposure to a multiple business group, Philips workflow solutions and services. This position partners with business leaders, marketing, quality, and distributors where you will guide the related stakeholders in application of all applicable regulatory requirements; ensuring gap analysis, regulatory assessment and impact for a successful regulatory submission and approval in each impacted country.

To succeed in this role, you should have the following skills and experience:

  • Experience in ASEAN Markets Medical Device Registrations
  • 3-5 years of experience in the medical device industry
  • Ability to understand regulatory environment as well compliance rules, guidelines and regulations
  • Autonomous and can do problem solving
  • Ability to various partners in other areas/teams of Philips
  • Experience in assembling technical documents
  • Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
  • Ability to work in a matrix organization and being agile
  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

Education:

Bachelor's Degree is required.

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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