Associated Regulatory Affairs Manager/Sr. Regulatory Affairs Specialist- CER

Job Description

Job Title

Job Description

In this role, you have the opportunity to 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 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

• Participate in the strategy of product registration in China from clinical perspective, ensure the implementation & updating of clinical strategy throughout the NMPA approval cycle.
• Participate in the Clinical Evaluation Plan Development process.
• Participate in the evidence generation processes to support Clinical Evaluation.
• Lead drafting and preparation of clinical evaluation materials including CER and oversea clinical data report to supporting timely NMPA registration.
• 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.
• Proactively address penitential risks for clinical evidence for regulatory submission and effective communication of risks if applicable
• Communicate with NMPA on the CER deficiency requirements.
• Provides China clinical regulations and specific requirements to product design teams.
• CER project management, including project plan, change management, status tracking and control, review and risk assessment.
• Assists clinical literature searches and reviews.
• Proofread clinical sections of regulatory submissions.
• Ensure the compliance of Greater China regulatory affairs activities with company policy and SOP.
• Assist the panel meeting with NMPA.

You are part of

Regulatory Affairs team. You will base in Beijing or Shanghai, and report to the 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.3 years’ experience in clinical research / development function, or related functional area.

·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. ·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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