Regulatory Specialist Sr

Job Description

Job Description

Job Title: Senior Regulatory Specialist
Location: 3200 Lakeside Drive, Santa Clara, CA 95054-2807
Duration: 12 Months
Work Arrangement: 100% Onsite
Pay Range: $50 - $55 per hour (W2)

We are seeking a “Senior Regulatory Specialist” to join one of our leading healthcare clients.

Position Overview
Seeking a Senior Regulatory Affairs Specialist to support global regulatory operations, international tenders, and regulatory documentation activities. This role requires strong project management, cross-functional leadership, and regulatory compliance experience.

Top Skills Required

• Global Tender & Project Management
• Cross-Functional Leadership
• Regulatory Operations & Global Compliance (MDR, International Submissions)

Key Responsibilities

• Lead end-to-end regulatory support for international tenders.
• Coordinate regulatory documentation, certifications, and compliance requirements.
• Manage project timelines, trackers, and deliverables to ensure on-time execution.
• Review and process regulatory documents, including LoA, PoA, CFGs, COEs, and Declarations of Conformity (DoC).
• Ensure compliance with EU MDR, international regulations, and Good Documentation Practices (GDP).
• Collaborate with Regulatory Affairs, Quality, Supply Chain, Legal, R&D, and international affiliates.
• Support process improvements, CAPA activities, and regulatory compliance initiatives.

Required Qualifications

• Experience in Regulatory Affairs, Regulatory Operations, or Global Regulatory Submissions.
• Strong project management and stakeholder management skills.
• Knowledge of EU MDR and international regulatory requirements.
• Excellent communication, organizational, and problem-solving abilities.
• Ability to manage multiple projects independently in a fast-paced environment.

Preferred Skills

• Global Regulatory Submissions
• Tender Management
• EU MDR
• CAPA
• Good Documentation Practices (GDP)
• SharePoint
• Process Improvement

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

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