Regulatory Specialist Sr

Regulatory Specialist Sr 12 Months Contract Santa Clara

CA 95054

08 AM - 05 PM Please find below the top three skills for the role:

Global Tender & Project Management:

Leads end-to-end regulatory support for international tenders with full accountability for timelines and deliverables

Cross-Functional Leadership:

Drives alignment and execution across multiple stakeholders, influencing without direct authority Regulatory Operations Expertise (Global): Deep knowledge of regulatory documentation, processes, and international requirements (e.g., MDR, global submissions)

Exempt/Non Exempt:

Non ExemptYears Experience:

We are seeking a highly driven and strategic Senior Regulatory Affairs Specialist to lead regulatory operations with a strong focus on global tender and regulatory affairs letters coordination and execution. This role is critical in ensuring timely, compliant, and high-quality regulatory deliverables to support international tenders, regulatory letters, and post-approval regulatory activities across multiple franchises. The ideal candidate operates with a high degree of independence, demonstrates strong cross-functional leadership, and can manage complex, multi-stakeholder deliverables with minimal oversight.

Key Responsibilities:

Tender Coordination & 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 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, Point 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 Qualifications & Skills Proven experience in Regulatory Affairs, Regulatory Operations, or international submissions Strong experience managing complex, cross-func ​#TB_ PH #ZRHC Why TalentBurst? At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.