Regulatory Affairs Executive - Bengaluru, Karnataka, India - InfraEyes

Description

• Handle regulatory affairs related to CE, ISO13485, ISO14001, FDA, CDSCO etc
• Work with other team members to provide regulatory inputs / documents
• Ensure that all regulatory standards and timelines are met
• Use of regulatory data base (Register) and IT tools
• Plan and track resource levels required and used for regulatory support requested.
• Regulatory review of raw materials, product specification and finished products.
• Maintaining data and files on registrations
• Handle regulatory audits

• Experience in European Regulatory Affairs for health products. Experience with Personal Care products would be desirable.
• Good Communication Skills (Written and Oral)
• Experience in process or quality management
• Knowledge of regulatory requirements for the clinical evaluation of software for medical devices

• Regulatory reporting: 1 year (preferred)