Global Tender Regulatory Lead

GForce Life Sciences; Santa Clara (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

GForce Life Sciences is looking for a Senior Regulatory Affairs Specialist in Santa Clara, California. This role involves leading regulatory operations with a focus on global tender support and ensuring timely delivery of regulatory documentation.

The ideal candidate will have strong project management skills, experience in international regulatory submissions, and the ability to influence cross-functional teams without direct authority. This position is critical to navigating complex regulatory landscapes.

Qualifications

• Proven experience in Regulatory Affairs or Regulatory Operations.
• Experience managing complex cross-functional projects.
• Knowledge of global regulatory requirements such as EU MDR.

Responsibilities

• Lead end-to-end global tender regulatory deliverables.
• Serve as the point of accountability for regulatory activities.
• Develop and maintain tender trackers and documentation.
• Ensure compliance with regional and country-specific requirements.
• Act as a liaison to resolve regulatory challenges.

Skills

Regulatory Affairs

Project Management

Cross-Functional Leadership

Problem-Solving

Knowledge of Global Regulatory Requirements

Job description

GForce Life Sciences is looking for a Senior Regulatory Affairs Specialist in Santa Clara, California. This role involves leading regulatory operations with a focus on global tender support and ensuring timely delivery of regulatory documentation.

The ideal candidate will have strong project management skills, experience in international regulatory submissions, and the ability to influence cross-functional teams without direct authority. This position is critical to navigating complex regulatory landscapes.