Senior Regulatory Affairs Specialist

Experis; Santa Clara (CA); Hybrid; USD 58,000 - 77,000; Full time

Benefits offered by this job

Medical

Dental Plan

Vision Plan

401(k)

Weekly Pay

Job summary

Experis is seeking a Senior Regulatory Affairs Specialist in Santa Clara, CA for a hybrid 12-month contract. The role focuses on leading regulatory initiatives across international markets, assessing evolving regulations, and coordinating cross-functional plans to ensure quality and compliance.

The ideal candidate will drive audit readiness and governance reporting while guiding the Emerging Issues SME team as needed.

Qualifications

• 5-7 years of experience in regulated medical device/pharma/biotech industries in Regulatory Affairs or Regulatory Operations.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience implementing regulatory or compliance requirements across cross-functional organizations.
• Proven project management, organizational, and stakeholder-management skills; ability to influence without direct authority.
• Ability to work independently, manage multiple streams, and drive issues to resolution with mitigations.

Responsibilities

• Lead pan-franchise implementation of emerging global regulatory requirements across international markets.
• Assess new or changing international regulations to determine impacto n business impact, implementation needs, risks, and timelines.
• Coordinate cross-functional gap assessments and implementation plans to ensure regulatory requirements are integrated into quality systems, procedures, labeling, and operations.
• Support audit readiness by identifying compliance risks, quality system gaps, and remediation opportunities; track observations through completion.
• Drive regulatory operations and documentation activities, including change management, governance reporting, and process improvements.

Skills

Regulatory Affairs

Stakeholder Management

Project Management

Global Compliance

Cross-functional Leadership

Job description

Our client, a regulated medical device and life sciences organization is seeking a Senior Regulatory Affairs Specialist to join their team. As a Senior Regulatory Affairs Specialist, you will be part of the Regulatory Affairs and Compliance organization supporting Emerging Regulatory Issues and Global Regulatory Operations. The ideal candidate will have strong cross-functional stakeholder leadership, the ability to manage complex compliance initiatives with clear accountability, and a deep understanding of international regulatory requirements—aligning successfully in the organization.

Job Title

Senior Regulatory Affairs Specialist

Location

Santa Clara, CA - Hybrid (3 days onsite)

Contract

12 months with possible extension

Pay Range

$49/hr on W2

Responsibilities

• 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.
• Support audit readiness by identifying compliance risks, quality system gaps, and remediation opportunities; track observations and commitments through completion.
• Drive regulatory operations and documentation activities, including change management, governance reporting, and process improvements that enhance efficiency, visibility, and compliance.

Requirements

• 5-7 years of experience in a regulated medical device, pharmaceutical, biotechnology, or other highly regulated industry within Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, Compliance, or a related function.
• 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, including the ability to influence without direct authority.
• Ability to work independently, handle multiple streams simultaneously, and drive issues through resolution with effective mitigations.

What's in it for me?

• Opportunity to support continued market access by translating emerging global regulatory requirements into practical, compliant execution.
• Visibility into compliance governance through KPI dashboards, trackers, and management review metrics.
• Collaboration across Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and international affiliate teams to drive timely outcomes.
• Experience strengthening audit readiness by tracking remediation and supporting internal, external, and regulatory inspections as needed.
• Chance to serve as an interim lead for the Emerging Issues SME team, supporting prioritization, coordination, and delivery.

Upon Completion Of Waiting Period Consultants Are Eligible For

• Medical
• Dental Plan
• Vision Plan
• 401(k)
• Weekly Pay