INDIBA Group

Compliance

• Participate in regulatory processes to obtain market clearances through health ministries and regulatory authorities
• Support new claim submissions and product CE marking activities
• Ensure regulatory compliance in regions where medical devices are marketed, including the European Union, the United States, Japan, Australia and South Korea
• Support preparation and submission of medical device technical files and cosmetic product dossiers
• Ensure regulatory deliverables meet required quality standards and deadlines
• Coordinate workflows with colleagues and internal and external stakeholders
• Stay up to date with relevant legislation and regulatory requirements
• Support maintenance and development of Quality Management Systems, including ISO 13485 and MDSAP
• Obtain, update and maintain regulatory approvals worldwide for medical devices and cosmetic products

Regulatory Affairs Officer