Senior Regulatory Affairs Specialist - Compliance

Senior RA Specialist - Compliance

Location: Santa Clara, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $55.00 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

We are seeking an experiencedSenior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across multiple franchises and international markets. This role is responsible for assessing regulatory changes, coordinating impact assessments, driving implementation activities, and ensuring regulatory requirements are effectively integrated into quality systems, processes, and business operations.

The ideal candidate will have experience in Regulatory Affairs, Regulatory Compliance, Regulatory Operations, Quality Systems, or Compliance within a regulated medical device environment and possess strong project management and stakeholder leadership skills.

Key Responsibilities

Emerging Regulatory Issues Implementation

• Lead 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 implementation plans to ensure regulatory requirements are incorporated into quality systems, procedures, labeling processes, and business operations to support continued market access and compliance.
• Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliate teams to drive timely and compliant execution.
• Monitor implementation activities, identify risks, and drive issue resolution to support on-time compliance.

Compliance Governance & Audit Readiness

• Support audit readiness activities across Regulatory Affairs functions by identifying compliance risks, quality system gaps, and remediation opportunities.
• Track audit observations, remediation activities, and compliance commitments through completion.
• Develop and maintain KPIs, dashboards, trackers, and governance reports to provide visibility into implementation progress, compliance risks, and key deliverables.
• Support regulatory audit readiness activities and participate in internal, external, and regulatory inspections as needed.

Cross-Functional Leadership

• Act as a key liaison between Regulatory Affairs, Quality, Regulatory Compliance, Labeling, and international affiliates to resolve complex regulatory challenges.
• Facilitate cross-functional governance meetings and drive decision-making and accountability.
• Influence stakeholders and align priorities across multiple functions and geographies.
• Communicate implementation plans, risks, and progress updates to stakeholders and leadership.
• May serve as an interim lead for the Emerging Issues SME team, supporting prioritization, coordination, and execution of key activities.

Regulatory Operations & Documentation

• Lead change management activities associated with regulatory and procedural updates.
• Manage change order activities required to support regulatory and quality system updates.
• Support management of post-approval regulatory commitments and associated deliverables.
• Identify and implement process improvements to enhance efficiency, visibility, and compliance within regulatory operations.
• Maintain and enhance KPI dashboards / Management Review Metrics to ensure the health of the Product Approval Key Process.

Required Skills

• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience supporting implementation of regulatory or compliance requirements across cross-functional organizations.
• Strong project management, organizational, and stakeholder management skills.
• Ability to work independently and drive initiatives with minimal oversight.
• Ability to drive a problem through resolution and implement mitigations.
• Ability to handle multiple streams simultaneously with timely execution.

Required Experience

• 5–7 years of experience in medical device, pharmaceutical, biotechnology, or other highly regulated industry.
• Experience in Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, Compliance, or a related function within a regulated medical device industry.

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Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Client

This client is a leadinghealthcare innovator dedicated to improving lives worldwide through a diverse portfolio of medical devices, diagnostics, and nutrition products. With more than 140 years of medical innovation, the organization develops life-changing technologies and products that reach patients in more than 160 countries, spanning cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation. Teams here include biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals working across a global, multi-segment enterprise.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-16018Industry: Manufacturing & Operations

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