Posted on Oct 12th 2019

Senior Regulatory Affair Engineer

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

442858

保存职位

Job Title

Senior Regulatory Affair Engineer

Job Description

Position: Senior Regulatory Affairs Engineer

Grade: CG60

Location: Shenzhen

In this role, you have the opportunity to

  • Catch up for all the whole world new regulation and standard for defibrillator and related accessories
  • Provide regulatory guidance to the cross functional team;
  • Lead regulatory strategy on the assigned projects.

You are responsible for

  • Mainly responsible for standard Revie Board for the ECR SZ Team for ALS defibrillator and related accessories. Make sure that all the applied standard and regulation is been collected, and working with R&D to do the interpretation, training and support the project team to make sure that the related standard and regulation is been implemented in ECR SZ product.
  • Advise product design teams on regulatory strategy and requirements for specific new product /solutions
  • Responsible for product registration/approvals; Develop and take the ownership of China NMPA /EU MDR, and support the FDA PMA.
  • Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance
  • Develops and facilitates regulatory submission for new products/solution, existing products/solutions
  • Review and approve advertising, promotional items and labeling for regulatory compliance
  • Participate in and advise cross-functional product team on applicable regulations, requirements and standards;
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required

You are a part of

•Professional Regulatory Team, with around 20+ team peers globally.

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

  • Be familiar with active medical device standard will be plus.  Testing experience would be perfect.
  • BS in  science ,engineer or regulatory affairs;
  • Minimum 5 years’ experience in active medical device industry for RA or testing.
  • Be familiar with on EU MDD/MDR, FDA 21 CFR, and China NMPA requirements (preferably in Class III active device experiences in EU, NMPA and FDA);
  • Good English will be plus.
  • High efficiency on problem shoveling from RA perspective;
  • Capable of handling pressures during working;
  • Willing to communicate and cooperate with cross function team members;

 

 

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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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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