Posted on Oct 12th 2019

Regulatory Affairs Manager-CER

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

395569

保存职位

Job Title

Regulatory Affairs Manager-CER

Job Description

In this role, you have the opportunity to

Develop, modify and execute regulatory strategies and policies from clinical evaluation perspective for specific new products and solutions in China, include Precision Diagnosis (PD), Image Guided Therapy (IGT), Connected Care (CC) and medical products from Personal Health (PH).

You will lead Regulatory Affairs-CER team and resources to plan, facilitate and generate clinical evaluation report and other clinical sections for regulatory submissions and product registration, including for new products/solutions, existing products/solutions, local permits.

You will also support NMPA’s regulatory & clinical evaluation guideline development as the expert from industry.

You are responsible for

Lead the strategy of product registration in China from clinical perspective; ensure the implementation & updating of regulatory strategy throughout the NMPA approval cycle.

  • Advice on the evidence generation processes to support Clinical Evaluation.
  • Collaborate with cross-functional teams (e.g. R&D team, Complaints team), ensure the CER is completed according to the up to date NMPA requirements, Philips SOP/WI.
  • Lead the communication with NMPA on the CER deficiency requirements.  
  • Keep abreast of current tendency and timely delivers the latest CER related regulation, guidelines, CMDE feedback and concerns.
  • As leader/subject matter expert on China clinical regulations, provide expert clinical regulatory support, specific requirements to product design teams.
  • Regularly update the internal CER template with new CER requirements about new regulations and CMDE feedback.
  • Proofread clinical sections of regulatory submissions.
  •   Assists clinical literature searches and reviews.
  • Participant the panel meeting with NMPA.
  • Support the extension work on demand of NMPA (e.g. guideline updates).
  • Support the literature analysis for post market products on demand of NMPA

You are part of

Regulatory Affairs team. You will base in Beijing or Shanghai, and report to the Clinical Regulatory Affairs Director/Sr. Clinical Regulatory Affairs Manager, Greater China.

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

  • MS or PhD in Engineering, Science, Medical or Statistics/Biostatistics.5+ years’ experience in clinical research / development function, or related functional area. 3 years of experience in the medical device industry and technical environment.
  • A comprehensive understanding of the diverse Greater China medical device regulations, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner.
  • Proven experience in successfully representing organizations in industry associations
  • Experience in clinical trial and development of clinical protocol and investigation.
  • In-depth knowledge in NMPA CER drafting, review, and medical device registration.
  • Knowledge of applied statistics for the purposes of regulatory submission, claims substantiation and peer-reviewed publications.
  • Ability of apply statistical technique most well-suited for specific requests in a manner that ensures accurate and robust conclusions.

In return, we offer you

A path towards your most rewarding career. Succeeding in this role will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer ambitious health benefits, a flexible work schedule and access to local well-being focused activities. You will also enjoy a professional but fun workplace, a healthy work-life balance environment and an energetic, authentic, inventive, encouraging and dynamic team atmosphere.

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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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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