Description

As an International Regulatory Project Manager, you will play a key role in ensuring high-quality regulatory submissions for IVDs. Your day-to-day responsibilities will involve coordinating documents, maintaining approvals, and collaborating with various stakeholders to navigate the regulatory landscape.

Requirements

• •Bachelor’s or Master’s degree in Life Science, Data Science, or related subject, or equivalent experience
• •At least 5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical
• •Experience in diagnostics or pharmaceutical regulatory affairs
• •Advanced degree and experience in CDx considered an advantage
• •Ability to manage high complexity work and/or global projects, or equivalent experience
• •Proven ability to work autonomously

Tasks

• •Support high-quality regulatory submissions of IVDs
• •Coordinate and compile submission documents on time
• •Maintain regulatory approvals throughout the product lifecycle
• •Manage health authority notifications and submissions
• •Collaborate with functions, stakeholders, and external partners
• •Provide input on project and product regulatory strategy
• •Support international regulatory submissions with necessary data
• •Respond to Health Authority inquiries regarding submissions
• •Keep Affiliates informed about new products and process changes
• •Ensure understanding and communication of regulatory requirements