Regulatory Affair Specialist

Collabera; Santa Clara (CA); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

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

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory Operations

Project Management

Stakeholder Management

Audit Readiness

Cross-functional Collaboration

Global Regulatory

Job description

Pay Range: $45/hr to $50/hr

Job Title: Senior Regulatory Affairs Specialist

Work Type: Onsite

Contract Duration: 12 months, possible extension based on performance and business needs

Job Summary

We are seeking an experienced Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across multiple product franchises and international markets. This role will assess regulatory changes, coordinate impact assessments, and drive compliance initiatives across quality systems, procedures, labeling processes, and business operations. The ideal candidate will bring strong knowledge of international regulatory frameworks, regulatory operations, and quality systems within a highly regulated industry. The successful candidate will collaborate with cross functional stakeholders, manage implementation timelines, mitigate compliance risks, and maintain audit readiness. This position requires strong project management, organizational, and stakeholder leadership skills, along with the ability to manage multiple priorities independently.

Key Responsibilities

• Lead the implementation of emerging global regulatory requirements across multiple product franchises and international markets.
• Assess new and changing international regulations to identify business impacts, compliance gaps, implementation requirements, risks, and timelines.
• Coordinate cross functional gap assessments and develop implementation plans to integrate regulatory requirements into quality systems, procedures, labeling processes, and business operations.
• Collaborate with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and international affiliate teams to ensure timely and compliant execution.
• Monitor implementation progress, identify potential risks, resolve issues, and drive mitigation activities to meet compliance deadlines.
• Support audit readiness by identifying compliance risks, quality system gaps, remediation opportunities, and outstanding compliance commitments.
• Track audit observations, corrective actions, remediation activities, and compliance commitments through completion.
• Develop and maintain key performance indicators, dashboards, trackers, and governance reports to communicate implementation progress, risks, and deliverables.
• Facilitate cross functional governance meetings, support decision making, and align priorities across functions and international markets.
• Lead change management activities and coordinate change order processes associated with regulatory and quality system updates.
• Support the management of post approval regulatory commitments and associated deliverables.
• Maintain and enhance management review metrics and key performance indicator dashboards to monitor the effectiveness of product approval processes.
• Identify and implement process improvements that strengthen regulatory operations, improve reporting visibility, and support ongoing compliance.

Required Qualifications

• Five to seven years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, or a related function within a regulated industry.
• Experience working in medical devices, pharmaceuticals, biotechnology, or another highly regulated environment.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience supporting the implementation of regulatory or compliance requirements 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 teams without direct authority.
• Ability to independently manage multiple initiatives, resolve complex issues, implement mitigation strategies, and deliver results with minimal oversight

Preferred Qualifications

• Experience coordinating regulatory compliance initiatives across multiple international markets and product franchises.
• Experience supporting internal audits, external audits, regulatory inspections, and remediation activities.
• Experience developing compliance dashboards, key performance indicators, governance reports, and management review metrics.
• Experience managing regulatory change orders, procedural updates, and post approval commitments.
• Experience facilitating cross functional governance meetings and coordinating activities across geographically dispersed teams.

Benefits

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)