Posted on Oct 12th 2019

Site SCR Lead Multi-Modality Shenzhen

中国,广东,深圳

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,广东,深圳

Full time

455200

保存职位

Job Title

Site SCR Lead Multi-Modality Shenzhen

Job Description

In this role, you have the opportunity to


Set up and lead a team of Safety & Compliance Managers and Regulatory specialists and be the primary point of contact for, and spokesperson towards the business partners and country organizations, for all Personal Health (PH) products developed in the Innovation Site in Shenzhen. The Site Lead SCR Multi-Modality - Shenzhen is a partner for the Head of Safety Compliance and Regulatory (SCR) representing the Legal Manufacturer, to ensure that the products offered for approbation and registration “Local for Local” (L4L) and “Local for Global” (L4G) meet all the requirements in order to bring consumer products to the markets, complying with Philips policies, Safety standards and worldwide Regulations in a competitive environment.


You are responsible for

  • Setting up and leading a team with SCR specialists working with the Business partners to define product regulatory strategies, ensure product compliance, relevant product approbation and registration and support any product safety related complaints and investigations.
  • Acting as senior SCR specialist, supporting the Shenzhen Innovation team on household and Medical Device product development projects. This can include but is not limited to support in creation of compliance plans, Compliance Verification, Labeling verification, Safety Risk Assessment and Technical Documentation Files
  • Representing Philips in Regional and National regulatory/standardization committees with focus on products developed in Shenzhen, and in particular for Mother and Child Care, Grooming and Beauty and Oral Health Care products, ensuring the appropriate interpretation to support the business
  • Taking influence through pro-active participation and lobbying
  • Creating approbation registration plan, package per product per country, including where needed Notarizing, Approbation Documentation/ transferring approbation Package to Local Country Organization
  • Supporting Country Organizations in registration process and registering the product in the local Market
  • Communicating successful registration to Business for commercial release
  • Pro-actively bringing forward the agreed Philips Personal Health position
  • Preparing commenting, and voting on standardization proposals


You are a part of

The central PH Safety, Compliance and Regulatory team and report directly to the Senior Director Regulatory Affairs. Especially for the local products you will also work together with the Greater China Regulatory and Clinical Affairs team and report dotted line to the Head of Regulatory Affairs Greater China. The PH central SCR team consists of a base team with process owners and experts making sure the Philips Consumer Lifestyle products are safe and compliant when placed on the markets worldwide and any potential issues are dealt with in a responsible timely manner, and the Site SCR leads to ensure implementation for the business categories. The SCR team you will work with and are part of is a diverse and international team located in all development sites around the world and with counterparts in the markets.

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

  • Academic level of thinking, with minimum of 5 year work experience in commercial consumer lifestyle company
  • Extensive knowledge on (non-)Medical Device development standards (e.g. ISO13485) and regulations (e.g. 21CFR820, EU MDR)
  • Extensive experience with Design and Development Safety and Compliance standards
  • Proven track record in global approbation and registration activities of (non-) Medical Devices
  • Team player with leadership skills
  • Strong analytical skills and structured way of working
  • Affinity with Mother & Child Care, Grooming & Beauty, and Oral Health Care product

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 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.

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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