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TEMP_NEO_Senior Regulatory Affairs SpecialistHireTalent • Santa Clara, CA, United States
TEMP_NEO_Senior Regulatory Affairs Specialist

TEMP_NEO_Senior Regulatory Affairs Specialist

HireTalent • Santa Clara, CA, United States
22 hours ago
Salary
$54.49 hourly
Job type
  • Temporary
Job description

Senior Regulatory Affairs Specialist

Location: Santa Clara, CA 95054 (Onsite) Pay Rate: $54.49/hour (W2) Duration: 12+ Months Contract Client: Abbott

About the Role

We are seeking a highly motivated Senior Regulatory Affairs Specialist to lead regulatory operations with a strong focus on global tender management, regulatory documentation, and cross-functional coordination. This role is critical in ensuring timely, compliant, and high-quality regulatory deliverables that support international tenders, regulatory letters, and post-approval regulatory activities across multiple business franchises. The ideal candidate will thrive in a fast-paced environment, demonstrate strong leadership skills, and independently manage complex regulatory initiatives involving multiple stakeholders.

Top Skills Required

  • Global Tender & Project Management
  • Cross-Functional Leadership and Stakeholder Management
  • Global Regulatory Operations Expertise (EU MDR, International Submissions, Regulatory Documentation)

Key Responsibilities

  • Tender Coordination & Execution
    • Lead and manage end-to-end global tender regulatory deliverables, including certifications, regulatory documentation, and product compliance data.
    • Serve as the primary point of accountability for tender-related regulatory activities across multiple franchises.
    • Coordinate with international affiliates, manufacturing, quality, packaging, R&D, labeling, and other SMEs.
    • Develop and maintain tender trackers, timelines, and governance processes to ensure on-time completion.
    • Identify risks, escalate issues proactively, and implement mitigation strategies.
    • Ensure compliance with country-specific and regional regulatory requirements.
    • Develop KPIs and dashboards to monitor performance and support continuous improvement.
  • Regulatory Operations & Documentation
    • Review, coordinate, and track regulatory letters including LoA, PoA, controlled substance letters, and evidence of conformance.
    • Prepare and submit Certificates to Foreign Governments (CFGs), CFG-NEs, and COEs within FDA databases.
    • Review and oversee Declarations of Conformity (DoC), templates, and translations to ensure compliance with EU MDR and global regulations.
    • Support translation requests and review EU MDR DoC translations for accuracy.
    • Maintain compliance with Good Documentation Practices (GDP).
    • Execute and track labeling addendum requests.
  • Cross-Functional Leadership
    • Partner with Regulatory Affairs, Quality, Supply Chain, Legal, and international affiliates to resolve regulatory challenges.
    • Facilitate governance meetings and drive accountability across stakeholders.
    • Influence and align priorities across multiple functions and global teams.
  • Process Improvement & Governance
    • Identify opportunities to improve and automate regulatory operations and tender workflows.
    • Support change management initiatives, including updates to procedures, templates, and systems.
    • Maintain SharePoint repositories, trackers, and documentation systems.
  • Compliance & Issue Management
    • Identify compliance risks and quality system gaps.
    • Support CAPA investigations and remediation efforts.
    • Troubleshoot and resolve regulatory operational issues impacting deliverables.

    Qualifications

    • Bachelor's degree in a relevant scientific, regulatory, or related discipline.
    • Proven experience in Regulatory Affairs, Regulatory Operations, or international regulatory submissions.
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TEMP_NEO_Senior Regulatory Affairs Specialist • Santa Clara, CA, United States

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