Regulatory Affairs Specialist

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

The Senior Regulatory Affairs Specialist leads regulatory operations activities with a focus on global tender support, regulatory documentation, and post-approval regulatory activities. This role is responsible for ensuring timely, compliant, and high-quality regulatory deliverables to support international tenders, regulatory letters, and regulatory operations across multiple product areas. The position requires a high degree of independence, strong cross-functional leadership, and the ability to manage complex deliverables across multiple stakeholders.

Requirements

• Lead and manage end-to-end global tender regulatory deliverables, including regulatory documentation, certifications, and product compliance data.
• Serve as the primary point of accountability for tender-related regulatory activities across multiple franchises.
• Coordinate and align inputs from cross-functional stakeholders, including international affiliates, manufacturing, quality, packaging, R&D, and labeling teams.
• Develop and maintain tender trackers, timelines, governance structures, KPIs, and dashboards to support execution and visibility.
• Identify risks, escalated issues as needed, and implemented mitigation strategies to support timely deliverables.
• Ensure compliance with regional and country-specific regulatory requirements.
• Lead the review, coordination, and tracking of regulatory letters, including Letters of Authorization (LoA), Powers of Attorney (PoA), controlled substance letters, and evidence of conformance documents.
• Prepare, submit, and track Certificates to Foreign Governments (CFGs), CFG-NEs, and Certificates of Exportability (COEs) through applicable regulatory databases.
• Provide oversight and quality review of Declarations of Conformity (DoC), templates, and translations to ensure compliance with applicable regulations and standards.
• Support translation requests and review translated regulatory documentation for accuracy and consistency.
• Ensure adherence to Good Documentation Practices (GDP) across all regulatory deliverables.
• Execute and track labeling addendum requests.
• Act as a liaison between Regulatory Affairs, Quality, Supply Chain, Legal, and international affiliates to resolve regulatory challenges.
• Facilitate cross-functional meetings and support decision-making and accountability.
• Identify and implement process improvements and automation opportunities within regulatory operations and tender workflows.
• Support change management activities, including updates to procedures, templates, systems, trackers, and documentation repositories.
• Identify compliance risks and quality system gaps.
• Support CAPA investigations and remediation activities.
• Troubleshoot and resolve regulatory operational challenges impacting deliverables.

Qualifications

• Proven experience in Regulatory Affairs, Regulatory Operations, or international regulatory submissions.
• Experience managing complex cross-functional projects and deliverables.
• Knowledge of global regulatory requirements, including EU MDR and international market regulations.
• Strong project management, prioritization, and organizational skills.
• Demonstrated ability to influence stakeholders and drive alignment without direct authority.
• Strong critical thinking and problem-solving skills.
• Ability to work independently with minimal oversight and maintain accountability for outcomes.
• Experience coordinating global regulatory documentation, tenders, and regulatory operations activities.