Product Compliance Manager

• Be accountable for regulatory compliance for all Personal Health (PH) products developed in the Innovation Site in Shenzhen. Establish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities.

• Ensure safe product design and maintenance & established repeated release program.
• Coordinate with Test houses and Regional regulatory team to get products approbation for target markets.
• Consult with product and solutions teams to ensure timely, effective and efficient cut over to new requirements as necessary.
• Develop initiatives for standards development and/or suggest updates needed to allow standards to be compliant with current technologies.
• Recommend standards strategy to support Philips mission, vision, and strategy.
• Represent Philips on Technical Committees that are creating compendium or regulatory standards related to product or solution performance.
• Provide leadership direction to BG personnel on understanding, interpretation and implementation of standards and regulations.

• A professional site production & development regulatory team with international exposure. Directly report to regulatory compliance group lead.

• Education: Bachelor’s degree or above. Biomedical Engineering, Electronic, or Chemical preferred.
• Experience: More than 8 years of experience in product regulatory compliance, quality testing and approbation field in cosmetic appliance, medical devices, personal care or household appliances. Successful NMPA submission of medical device or cosmetics preferable. High Degree of experience working with Global Quality and Regulatory requirements with high dependencies of documented processes and deliverables.
• Competencies and skills:

• Problems solving. Familiar with analytical tools, such as FMEA, process control plan
• Working knowledge of appropriate global regulations and standards in areas of cosmetic appliance, medical devices, personal care or household appliances
• ISO9001 & ISO13485
• Experience of working in Global Matrix organization
• High morale with excellent work ethic, integrity and attitude.
• Teamwork orientated, Self-motivated & able to Work Independently
• Good skills of project management and communication, good English both verbal and written.

Philips