Posted on Oct 12th 2019

Sr. Regulatory Affair Manager

中国,江苏,苏州

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,江苏,苏州

Full time

431490

保存职位

Job Title

Sr. Regulatory Affair Manager

Job Description

In this role, you have the opportunity to

  • Provide regulatory input at the earlier stage of product design and development to make sure product compliance with global standard and regulatory.
  • Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China. Mainly focus on localized innovation projects.
  • Communicates with relevant competent authorities, agents, distributors, and local sales offices to ensure the most efficient path to application approval.
  • Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements. To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.

You are responsible for

  • Participate in and advise cross-function new product/solution development teams on product design, registration applications, requirements, and standards (not in the field)
  • Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions.
  • Review development quality reports and plans to ensure that the information required for submissions is adequate.
  • Plan, generate, and coordinate regulatory submissions for product/solution licensing.
  • Coordinate testing required to support regulatory submissions.
  • Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)
  • Review changes in existing products to determine need for new/revised submissions or document reason for no submission.
  • Maintain existing regulatory filings /Licenses, managing updates and related change control processes (generally at the BIU and field level)

You are a part of

Great China RA Team (IGT-S I2M)

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

  • Bachelor’s degree above, major in medical or engineering
  • More than 8 years RA experiences on MD, especially L4L and L4G, including NMPA, CE and 510k.
  • More than 3 years R&D experience on MD.
  • Well known the Quality Management Systems (QMS) and full of GMP audit experiences.
  • Be familiar with China and international regulations
  • Good in written and spoken in English and Mandarin
  • Excellent communication and interpersonal skill
  • Self-starter and able to work both autonomously and as part of a team
  • Prefer to have project management, time management experience
  • Take owner ship on problem solving and continues improvement.

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:

  • A market conform salary
  • 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 2.5 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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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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