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Philips Regulatory Affairs Assistant Manager in Beijing, China

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Your challenge

  • Government relations: Familiar with the officials and understanding their requirements for timely approvals.

  • Regulations: In depth-understanding and application of SFDA and CQC regulations and the related regulatory process.

  • Technical expertise: Knowledge of process and methods and medical product area such as product specifications, product developments / expansions and product safety.

  • Understanding of the IEC and related GB standard for good communications with the BIU and CFDA or CQC testing lab’s engineers.

  • Excellent communications skill with internal and external customers.

Duties and responsibilities include:

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.

  • Create detailed written regulatory plans that can be used to target domestic and international shipment dates.

  • Develop and take the ownership of China CFDA submissions

  • Support Key market RA team on global registrations

  • Establish active communications with regulatory agencies in China.

  • Review and approve advertising, promotional items and labeling for regulatory compliance

  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.

  • Communicate application progress to internal stakeholders

  • Collaborate with worldwide colleagues regarding license renewals and updates

  • Maintain regulatory files and tracking databases as required

Requirements:

  • BS in engineering discipline or equivalent education, experience, training.

  • At least 5 years regulatory experience in medical device industry.

  • Experience in China local manufactured or local developed products will be a plus.

  • Strong understanding of China FDA and other major international regulations

  • Be able to manage multiple tasks and perform with accuracy and a high attention to detail

  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.

  • Proficient in English communication including reading, writing, speaking and listening.

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