Philips Senior Regulatory Affairs Project Manager 

India, Karnataka 

607212504

Senior Regulatory Affairs Project Manager

Senior Regulatory Affairs Project Manager

Quality Culture/Process Improvement

– Maintain technical expertise in core job functions including all applicable QSPs, WI, Forms, Philips training, and regulatory body requirements.Regulatory Proficiency– Maintain expertise in the interpretation of domestic and international regulations and laws as they apply to the licensing, registration, manufacture, shipping, and sale of assigned medical devices, with a special focus on mature markets: USA, Canada, and EU.

mQMS Support and CD Material Controls Support

• Lead DCO process for procedure release after final procedures are drafted. Applicants must be able to understand and follow complex processes and communicate effectively to ensure all required deliverables are in place prior to Quality System Procedure releases.

• Help validate processes through redline reviews, compliance mapping, and process simulation. Applicants must possess some Regulatory knowledge to be able to effectively review draft procedures, provide valuable feedback, and map draft procedures to applicable Standards and Regulations.

• Map roles to processes within completed procedures for Regulatory QSD's. Applicants must have good organizational skills and attention to detail.

• Help place and lift Regulatory Blocks per the CD Material Control Plan. Applicants must have good problem-solving skills to be able to investigate exceptions and resolve issues surrounding new process.

Indicate if this role is an office/field/onsite role.
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