Senior Regulatory Specialist

Job Title: Senior Regulatory Specialist

Location: 3200 Lakeside Drive, Santa Clara, CA 95054-2807

Duration: 12 Months

Work Arrangement: 100% Onsite

Position Overview

We are seeking a Senior Regulatory Affairs Specialist to lead global regulatory operations with a strong focus on international tenders, regulatory documentation, and post-approval regulatory activities. This role requires a highly independent professional who can manage complex projects, coordinate across multiple stakeholders, and ensure timely regulatory compliance.

Top Required Skills

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

Key Responsibilities

Global Tender Management

• Lead end-to-end regulatory support for international tenders.
• Coordinate regulatory documentation, certifications, and compliance data.
• Manage tender timelines, trackers, KPIs, and project deliverables.
• Identify risks and implement mitigation strategies to ensure on-time submissions.
• Ensure compliance with regional and country-specific regulatory requirements.

Regulatory Operations

• Review, coordinate, and track regulatory documents and letters (LoA, PoA, CFGs, COEs, DoCs, etc.).
• Prepare and submit Certificates to Foreign Governments (CFGs) and related documentation.
• Review MDR Declarations of Conformity (DoC) and translations for accuracy and compliance.
• Support translation requests and labeling addendum activities.
• Ensure adherence to Good Documentation Practices (GDP).

Cross-Functional Leadership

• Partner with Regulatory Affairs, Quality, Supply Chain, Legal, Manufacturing, R&D, Packaging, Labeling, and international affiliates.
• Facilitate cross-functional meetings and drive accountability across teams.
• Influence stakeholders and align priorities without direct authority.

Process Improvement & Compliance

• Improve regulatory processes, workflows, and documentation systems.
• Maintain SharePoint repositories, trackers, and regulatory records.
• Support CAPA activities and address compliance risks.
• Troubleshoot regulatory operational issues and drive continuous improvement initiatives.

Required Qualifications

• Experience in Regulatory Affairs, Regulatory Operations, or Global Regulatory Submissions.
• Strong background managing complex cross-functional projects independently.
• Knowledge of global regulatory requirements, including EU MDR and international markets.
• Advanced project management, organizational, and prioritization skills.
• Excellent communication, stakeholder management, and problem-solving abilities.
• Ability to work independently with minimal supervision and high accountability.

Preferred Skills

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

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.