Senior Regulatory Specialist

Job Title: Senior Regulatory Specialist

Job Location: Santa Clara, CA

Job Type: Contract

Job Overview:

Pay Range: $49.49hr - $54.49hr

Tender Coordination and Execution:

• 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.

• 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.

• 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.

• 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.

• Identify and address compliance risks and quality system gaps.
• Support CAPA investigations and remediation activities.
• Troubleshoot and resolve regulatory operational challenges impacting deliverables.

• 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.