Regulatory Affairs Associate

Mission

You will report to the Regulatory Affairs Director. He/she will perform and manage regulatory activities within a highly regulated, fast-paced industry to ensure that Company objectives are achieved in compliance with regulatory requirements. He/she will be in charge for managing all RA aspects associated with the development of new product projects and for communication with competent authorities according to the geographical area responsibilities.

Challenges we trust you with

• Manage simple to moderate complexity regulatory projects
• Identify laws, regulations, standards and guidance applicable to the organization in the target markets as defined by the management and according to the product specificities
• Ensure regulatory compliance with applicable standards, directives and regulations
• Identify deliverable documents required for market registration and conduct pre-survey reviews of these deliverables
• Work proactively and closely with cross-functional teams on new product/feature launches according target market requirements. Provide guidance to the same
• Assist RA management with activities related to regulatory inspections. Fulfill requests from other departments related to regulatory information and documentation

What we value

You have:

• A Scientific degree (Pharma, Electromechanics, Chemistry etc.) with a keen interest in understanding the technical aspects of the product
• 0-3 years of industrial experience
• Good problem-solving skills, analytical capacity, and the ability to understand and follow instructions independently.
• A proactive approach, capable of seeking information autonomously and ensuring timely and high-quality document deliverables.
• Proficiency in English and secondary in French
• Basic knowledge of European and/or US regulation on Medical Devices is a plus

Life at IBA