Regulatory Quality & Trust Lead (Safety & Compliance)

Aquent; Campbell (CA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Aquent partners with a leading technology company to drive regulatory excellence and quality across high-stakes projects. This role puts you at the center of shaping best practices and navigating complex regulatory landscapes to ensure safety, reliability, and trust in advanced systems.

You will guide design and analysis, identify risks, and steer submissions while collaborating with regulatory, quality, clinical, product, design, and engineering teams to deliver scalable compliance solutions.

Qualifications

• Proficiency in registration and auditing processes.
• Exceptional communication and influence skills across diverse stakeholders.
• Strong understanding of information governance principles and practices.
• Demonstrated project scoping and execution capabilities.
• Expertise in regulatory compliance across relevant domains.
• Proven risk management abilities: identification, assessment, and mitigation.
• Comprehensive knowledge of industry standards, regulations, and reporting requirements.
• Solid project/program management skills with track record of delivery.
• Domain-specific knowledge in quality, regulatory, safety and trust.
• Technical, clinical, and partner knowledge relevant to advanced systems.
• Unwavering commitment to product excellence and integrity.
• Strong business acumen and alignment with organizational objectives.

Responsabilités

• Provide expert guidance on design and analysis for complex projects, establishing robust regulatory frameworks and mentoring teams on critical trade-off decisions.
• Facilitate early identification of risk elements for specific projects, developing and implementing contingency plans with project teams.
• Anticipate regulatory responses through scenario planning and advise on effective regulatory management strategies.
• Establish and manage internal compliance processes, driving accountability and alignment with privacy policies.
• Identify opportunities for process improvements, including automation, and champion new, efficient processes.
• Conduct and analyze in-depth regulatory research to inform strategic direction and collaborate on complex regulatory strategies.
• Drive preparation and execution of regulatory submissions with meticulous planning and quality.
• Serve as the primary regulatory expert on cross-functional teams and share best practices across the organization.
• Interpret existing regulations precisely and build internal advocacy networks across departments.
• Understand political processes and their impact on public policy and regulatory laws.
• Identify unmet quality and compliance needs and create scalable solutions.
• Contribute domain expertise to regulatory, quality, clinical, product, design and engineering teams.
• Plan and coordinate meetings with regulatory agencies for clear communication and efficient reviews.
• Analyze data from events with extended recovery times to identify root causes and drive solutions.
• Synthesize recurring issues to propose lasting fixes and drive continuous improvement across operations.
• Partner with vendors and internal teams to fix process breakdowns and drive corrective actions.
• Contribute to weekly reports and executive communications for transparency.

Connaissances

Registration and auditing

Communication & influence

Information governance

Project scoping & execution

Regulatory compliance

Risk management

Standards & reporting

Project/program management

Regulatory domain expertise

Technical/clinical knowledge

Product integrity

Business acumen

Description du poste

Aquent partners with a leading technology company to drive regulatory excellence and quality across high-stakes projects. This role puts you at the center of shaping best practices and navigating complex regulatory landscapes to ensure safety, reliability, and trust in advanced systems.

You will guide design and analysis, identify risks, and steer submissions while collaborating with regulatory, quality, clinical, product, design, and engineering teams to deliver scalable compliance solutions.