Regulatory Specialist Sr

Title: Sr Regulatory Specialist
Location: Santa Clara, California (100% Onsite)
Duration: 12 Months
Shift Time: 8am to 5pm
Pay Range : $40/hr to $46/hr (On W2)

We are looking for a “Sr Regulatory Specialist“ to join one of our Fortune 500 clients.

Job Responsibilities:

• Lead and own end-to-end global tender regulatory deliverables, including regulatory documentation, certifications, and product compliance data
• Serve as the central point of accountability for tender-related regulatory activities across franchises
• Drive alignment and coordinate inputs across SMEs, including international affiliates, manufacturing, quality, packaging, R&D, and labeling teams
• Develop and manage tender trackers, timelines, and governance structures to ensure visibility and on-time execution
• Identify risks, proactively escalate issues, and implement mitigation strategies to ensure tender success and timeliness
• Ensure compliance with regional and country-specific regulatory requirements.
• Develop and monitor KPIs and dashboards to track performance and drive continuous improvement
• Regulatory Operations & Documentation
• Lead the review, coordination, and tracking of regulatory letters (LoA, PoA, controlled substance letters, evidence of conformance, etc)
• Executes preparation and submission of Certificates to Foreign Governments (CFGs), CFG-NE, COEs in the FDA database
• Provide oversight and quality review of Declarations of Conformity (DoC), DoC templates, and translations, ensuring compliance with MDR and global standards and regulations.
• Support translation requests through the translations portal.
• Review EU MDR DoC translations for accuracy and consistency
• Ensure adherence to Good Documentation Practices (GDP) across all deliverables
• Executes and tracks addendum labeling requests
• Cross-Functional Leadership
• Act as a key liaison between Regulatory Affairs, Quality, Supply Chain, Legal, and international affiliates to resolve complex regulatory challenges
• Facilitate cross-functional governance meetings and drive decision-making and accountability
• Influence stakeholders and align priorities across multiple functions and geographies
• Process Improvement & Governance
• Identify and implement process improvements and automation opportunities within regulatory operations and tender workflows
• Lead and support change management activities, including updates to procedures, templates, and systems
• Maintain and enhance trackers, SharePoint repositories, and documentation systems to improve efficiency
• Compliance & Issue Management
• Identify and address compliance risks and quality system gaps
• Support CAPA investigations and remediation activities
• Troubleshoot and resolve regulatory operational challenges impacting deliverables.
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• Proven experience in Regulatory Affairs, Regulatory Operations, or international submissions
• Strong experience managing complex, cross-functional initiatives independently
• Demonstrated expertise in global regulatory requirements (e.g., EU MDR, international markets)
• Advanced project management, prioritization, and organizational skills
• Excellent stakeholder management and influencing skills, including the ability to drive alignment without direct authority
• Strong critical thinking and problem-solving capabilities
• Ability to operate with minimal oversight and high accountability for outcomes.

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button