Regulatory Specialist Diagnostics

The Opportunity:

As a Regulatory Specialist, you will be responsible for compiling documents and deliverables to support planned product registration timelines. You will maintain product registration throughout a product’s lifecycle by applying successful regulatory change control and ensuring alignment with local and regional registration requirements. You will work independently within guidelines and policies, acting as a resource for colleagues with less experience and providing functional guidance.

Your key responsibilities will include:

• Submission Management: Coordinate and prepare document packages for regulatory submissions, license renewals, and annual registrations for new and mature products.

• Lifecycle Maintenance: Support currently marketed products regarding labeling, manufacturing changes, and technical file maintenance to ensure ongoing compliance with Global Regulatory directives.

• Information Systems: Maintain and create product information and reports within the Regulatory Information Management System and support documentation management workflows.

• Stakeholder Collaboration: Interface with internal stakeholders and external partners (Health Authorities/Notified Bodies) to promote successful registration strategies and answer submission-related inquiries.

• Global Support: Support international regulatory submissions by providing needed data and documents, keeping Affiliates informed of new products, projects, or process changes.

• Compliance & Strategy: Keep abreast of regulatory procedures and changes, recommending strategies for the earliest possible approvals of clinical trials applications and improving tracking/control systems.

Who you are:

You are a proactive professional with strong communication skills, a resolution-oriented mindset, and the ability to manage complex documentation in a regulated environment.

Requirements and Qualifications:

• Education: Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, or related fields.

• Experience: Proven experience in Regulatory, R&D, Quality, Operations, or Clinical teams, specifically including documentation and country registration tasks. Experience with In Vitro Diagnostics (IVD) is a plus.

• Languages: Advanced English proficiency is a requirement.

• Core Competencies: * Proactive with strong self-management capabilities.

• Flexible, adaptable, and a curious "learning enthusiast."

• Process improvement oriented and able to work independently.

Relocation benefits are not available for this job posting.