Regulatory & Quality Excellence Specialist

Aquent (United States); Campbell (CA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Aquent, a global leader in talent solutions, is partnering with a pioneering technology company to drive regulatory excellence and quality in high-stakes operations. You will shape compliance programs, mentor teams, and influence strategic decisions across engineering, product, and clinical domains.

This role focuses on defining best practices, guiding regulatory strategy, and enabling continuous improvement in safety, reliability, and trust for advanced systems.

Qualifikationen

• Proficiency in registration and auditing processes.
• Strong communication and influence skills.
• Understanding of information governance and regulatory standards.
• Experience in scoping projects and executing regulatory work.
• Demonstrated risk management abilities.
• Familiarity with reporting and compliance standards.
• Project/program management capabilities.
• Domain knowledge in quality, regulatory, safety, and trust.
• Technical, clinical, and partner knowledge.
• Commitment to product excellence.

Aufgaben

• Provide regulatory design and analysis guidance for complex projects.
• Identify risks and mentor teams on trade-off decisions.
• Develop contingency plans with project teams.
• Anticipate regulatory responses and advise on actions.
• Establish internal compliance processes and governance.
• Identify process improvements including automation.
• Conduct regulatory research to inform strategy.
• Drive regulatory submissions planning and maintenance.
• Serve as regulatory expert on cross-functional teams.
• Interpret regulations and build internal advocacy networks.
• Understand political processes and impact on policy.
• Identify unmet quality, regulatory, and compliance needs.
• Contribute to regulatory, quality, clinical, product, design, and engineering domains.
• Coordinate meetings with regulatory agencies and stakeholders.
• Analyze data from events to identify root causes and improvements.
• Synthesize issues and drive corrective actions across end-to-end processes.
• Collaborate with vendors to address process breakdowns.

Kenntnisse

Registration & auditing

Regulatory compliance

Information governance

Project scoping

Risk management

Standards & reporting

Program management

Quality & safety

Technical & clinical knowledge

Business acumen

Jobbeschreibung

Aquent, a global leader in talent solutions, is partnering with a pioneering technology company to drive regulatory excellence and quality in high-stakes operations. You will shape compliance programs, mentor teams, and influence strategic decisions across engineering, product, and clinical domains.

This role focuses on defining best practices, guiding regulatory strategy, and enabling continuous improvement in safety, reliability, and trust for advanced systems.