Quality, Regulatory, Safety and Trust Specialist [AQ-25430]

Aquent; Campbell (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

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

Job description

Aquent, a global leader in talent solutions, is thrilled to partner with a pioneering technology company that stands at the forefront of innovation. This industry leader is dedicated to developing advanced solutions where safety, reliability, and trust are paramount. Join a team where your expertise will directly influence the integrity and efficiency of critical operations for groundbreaking technologies, driving strategic initiatives and ensuring the highest standards of quality and compliance across various industries.

Step into a pivotal role that puts you at the heart of defining best practices and shaping the regulatory landscape for transformative technologies. This is an extraordinary opportunity to leave a lasting mark on the future of the industry, where your contributions will directly enhance the safety and seamless functioning of advanced systems. You’ll be a key driver of strategic initiatives, tackling complex regulatory challenges, and ensuring unparalleled quality and compliance in high-stakes projects, making a tangible impact on cutting-edge solutions.

What You’ll Do

• Provide expert guidance on design and analysis for complex projects, establishing robust regulatory frameworks and proactively identifying potential risks and implications, while mentoring teams on critical trade‑off decisions.
• Facilitate the early identification of risk elements for specific projects, developing and implementing comprehensive contingency plans in close collaboration with project teams.
• Anticipate regulatory responses through insightful scenario planning, clearly communicating potential risks, and advising on effective regulatory management strategies and courses of action for projects.
• Establish and manage internal compliance processes, driving accountability, securing necessary resources, and ensuring seamless alignment with all compliance and privacy policies.
• Identify opportunities for and implement significant process improvements, including automation, and champion the widespread adoption of new, efficient processes.
• Conduct and analyze in‑depth regulatory research to inform strategic direction, collaborating on complex regulatory strategies and resolving intricate issues with minimal guidance.
• Drive the preparation, meticulous planning, coordination, execution, and ongoing maintenance of regulatory submissions, ensuring impeccable quality and unwavering compliance.
• Serve as the primary regulatory expert on cross‑functional teams, critically evaluating submission management processes and sharing best practices across the organization.
• Interpret existing regulations and guidance documents with precision, building strong internal advocacy networks across various departments to foster a culture of compliance.
• Understand political processes and their profound impact on public policy and regulatory laws, leveraging this insight to navigate complex landscapes.
• Identify present and future unmet quality, regulatory, and compliance needs, generating novel approaches and creating scalable, sustainable solutions.
• Contribute invaluable domain expertise to regulatory, quality, clinical, product, design, and engineering teams, fostering interdisciplinary excellence.
• Plan, coordinate, prepare, and execute productive meetings with regulatory agencies, facilitating clear communication and efficient review processes.
• Analyze data from events with extended recovery times to understand root causes, collaborating effectively with cross‑functional stakeholders and vendors to drive solutions.
• Synthesize recurring issues across events to propose and implement lasting fixes, thereby driving continuous improvement initiatives across all operations.
• Partner strategically with vendors and internal teams to pinpoint process breakdowns and drive effective corrective actions within end‑to‑end processes.
• Contribute to the population of key weekly reports and communications for executive audiences, ensuring transparency and informed decision‑making.

Must‑Have Qualifications

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

Nice‑to‑Have Qualifications

• Experience in process auditing, particularly within supply chain or logistics, to identify and address inefficiencies and optimize workflows.
• Prior experience in vendor management, focusing on effective issue resolution and collaborative partnerships.
• Adeptness at quickly learning and efficiently utilizing complex technical tools and platforms.

Client Description

Join one of the world’s most iconic technology visionaries, consistently recognized as a global leader in digital innovation. Our client offers a high‑energy, collaborative environment where you will work alongside some of the industry’s brightest minds. This is a unique opportunity to gain experience within a multi‑billion dollar tech giant, contributing to high‑visibility projects that influence how the world connects and learns. For professionals looking to elevate their career, there is no better place to build your portfolio and witness large‑scale innovation in action.