Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist 
12 month contract 
Must be able to work on a W2 
100% on-site in Santa Clara, CA 

SUMMARY
Our client, a company operating within the regulated medical device industry, has engaged GForce Life Sciences to provide a Senior Regulatory Affairs Specialist. This position will support the implementation of emerging global regulatory requirements across multiple franchises and international markets. The role is responsible for assessing regulatory changes, driving impact assessments, and ensuring effective integration of requirements into quality systems and business operations.

DUTIES / EXPECTATIONS OF ROLE

• Lead the pan-franchise implementation of emerging global regulatory requirements across international markets.
• Assess new or changing international regulations to determine business impact, implementation needs, risks, and timelines.
• Coordinate cross-functional gap assessments and develop implementation plans to incorporate regulatory requirements into quality systems, labeling, and processes.
• Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliates to ensure timely and compliant execution.
• Monitor implementation activities, identify risks, and support issue resolution to achieve on-time compliance.
• Support audit readiness activities by identifying risks, gaps, and remediation opportunities, and track progress through dashboards and reports.
• Act as a liaison between Regulatory Affairs, Quality, Regulatory Compliance, Labeling, and international affiliates to resolve complex challenges.
• Facilitate governance meetings and influence stakeholder priorities across functions and geographies.
• Manage change management activities related to regulatory and procedural updates, including change orders and post-approval commitments.
• Identify and implement process improvements to enhance efficiency, visibility, and compliance within regulatory operations.

MANDATORY REQUIREMENTS

• 5-7 years of experience in Medical Device, Pharmaceutical, Biotechnology, or a highly regulated industry.
• Experience in Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, or related functions within a regulated medical device environment.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Proven experience supporting the implementation of regulatory or compliance requirements across cross-functional teams.
• Strong project management, organizational, and stakeholder management skills.
• Ability to work independently with minimal oversight, drive initiatives, and resolve complex problems.
• Capability to handle multiple projects simultaneously and ensure timely execution.

NICE TO HAVE

• Experience managing regulatory commitments and post-approval activities.
• Background supporting regulatory governance, audit readiness, and process improvement initiatives.
• Previous experience supporting cross-functional teams in global regulatory environments.
• Knowledge of KPI dashboards, management review metrics, and regulatory change management processes.