Are you ready to drive impactful regulatory initiatives in a company that values innovation and growth?

Join our team in Moss as Regulatory Affairs Officer/Specialist and contribute directly to the global reach of our in-vitro diagnostic products. This role offers you the chance to ensure robust regulatory compliance across markets from USA to Asia, playing a key part in bringing innovative diagnostics to patients worldwide.

What we offer

• Global Scope: Engage in regulatory activities that enable our diagnostics to reach diverse international markets.
• Professional Growth: Enhance your expertise within a fast-growing, innovation-driven company.
• Dynamic Environment: Work alongside experts in an innovative and supportive team, helping you expand your skill set in a global regulatory landscape.

Key responsibilities

• Product Registrations: Prepare, submit, and manage regulatory documentation for compliance with IVDR and other global standards.
• Regulatory Strategy: Support market expansion by developing and executing regulatory plans.
• Quality Management: Maintain our Quality Management System per IVDR, ISO 13485, and US 21CFR820 standards.
• Regulatory Intelligence: Monitor and interpret regulatory updates to ensure continuous compliance.

Required Skills and Qualifications

• Education: Master’s degree in Science, Technology, Biology, Chemistry, or related field.
• Experience: 2-4 years in regulatory affairs within IVD or medical devices; knowledge of IVDR, ISO 13485, and experience with FDA processes is a plus.
• Personal Attributes: Detail-oriented, organized, and adaptable with strong teamwork skills.

If you're a regulatory professional who’s ready to make a difference in global healthcare, we’d love to hear from you! Apply now to take the next step in your career with Gentian.