Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist

Location: Santa Clara, CA 95054 (Onsite) (Local Candidates only)

Duration: 12+ Months Contract

Schedule: Monday–Friday, 8:00 AM – 5:00 PM

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.
• Strong experience managing complex cross-functional projects independently.
• Knowledge of global regulatory requirements, including EU MDR and international markets.
• Excellent project management, prioritization, and organizational skills.
• Strong stakeholder management and communication abilities.
• Demonstrated ability to influence and drive alignment without direct authority.
• Strong analytical, critical-thinking, and problem-solving skills.
• Ability to work independently with minimal supervision and high accountability.