Senior Global Regulatory Affairs Specialist

Collabera; Santa Clara (CA); Sur place; USD 62 000 - 69 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

Parking/Transit

Paid time off

Paid sick days

Paid vacation

Paid parental leave

Paid holidays

Résumé du poste

Collabera is seeking a Senior Regulatory Affairs Specialist to support global regulatory requirements across multiple product franchises and international markets. The role requires coordinating impact assessments, managing timelines, and driving compliance across quality systems, labeling processes, and business operations.

The candidate should have strong knowledge of international regulatory frameworks, regulatory operations, and quality systems, with proven project management and stakeholder

Qualifications

• 5–7 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, or a related function.
• Experience in medical devices, pharmaceuticals, biotechnology, or another highly regulated environment.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience supporting regulatory or compliance implementations across cross-functional organizations.
• Demonstrated project management skills, including planning, execution, risk management, and tracking deliverables.
• Strong stakeholder management and communication skills with the ability to influence without direct authority.
• Ability to independently manage multiple initiatives, resolve complex issues, and deliver results with minimal oversight.

Responsabilités

• Lead the implementation of emerging global regulatory requirements across product franchises and international markets.
• Assess new and changing international regulations to identify business impacts, compliance gaps, timelines and risks.
• Coordinate cross-functional gap assessments and develop plans to integrate regulatory requirements into quality systems and processes.
• Collaborate with Regulatory, Quality, Labeling, Supply Chain, Legal, and affiliates to ensure timely compliance.
• Monitor progress, identify risks, resolve issues, and drive mitigations to meet deadlines.
• Support audit readiness by identifying risks and remediation opportunities and tracking commitments.
• Track audit observations and corrective actions through completion.
• Develop KPIs, dashboards, and governance reports to communicate progress and risks.
• Facilitate cross-functional governance meetings and align priorities across teams.
• Lead change management and change order processes for regulatory and quality updates.
• Support post-approval regulatory commitments and related deliverables.
• Maintain management review metrics for product approval processes.
• Identify and implement process improvements to strengthen regulatory operations.

Connaissances

Regulatory Operations

Project Management

Stakeholder Management

Audit Readiness

Cross-functional Collaboration

Global Regulatory

Description du poste

Collabera is seeking a Senior Regulatory Affairs Specialist to support global regulatory requirements across multiple product franchises and international markets. The role requires coordinating impact assessments, managing timelines, and driving compliance across quality systems, labeling processes, and business operations.

The candidate should have strong knowledge of international regulatory frameworks, regulatory operations, and quality systems, with proven project management and stakeholder