Quality, Regulatory, Safety and Trust Specialist

Aquent (United States); Campbell (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Registration & auditing

Regulatory compliance

Information governance

Project scoping

Risk management

Standards & reporting

Program management

Quality & safety

Technical & clinical knowledge

Business acumen

Job description

Aquent, a global leader in talent solutions, is partnering with a pioneering technology company at the forefront of innovation. This organization is dedicated to developing advanced solutions that prioritize safety, reliability, and trust, shaping the future of various industries. Join a team that values rigorous standards and groundbreaking approaches, making a tangible impact on cutting-edge technologies and operational excellence.

This is an exceptional opportunity to step into a pivotal role where your expertise will directly influence the integrity and efficiency of critical operations. As a key contributor, you will drive strategic initiatives, solve complex regulatory challenges, and ensure the highest standards of quality and compliance are met. Your work will directly contribute to the safety and seamless functioning of advanced systems, playing a crucial role in the continuous improvement and success of high-stakes projects. You'll be at the forefront of defining best practices, collaborating with diverse teams, and shaping the regulatory landscape for innovative technologies.

What You'll Do:

• Provide expert guidance on design and analysis for complex projects, establishing regulatory frameworks and identifying potential risks and implications, while mentoring teams on critical trade-off decisions.
• Facilitate early identification of risk elements for specific projects, developing and implementing contingency plans in collaboration with project teams.
• Anticipate regulatory responses through scenario planning, communicating risks, and advising on regulatory management and courses of action for projects.
• Establish and manage internal compliance processes, driving accountability, securing resources, and ensuring alignment with compliance and privacy policies.
• Identify opportunities for and implement process improvements, including automation, and promote the adoption of new processes.
• Conduct and analyze regulatory research to inform strategy, collaborating on regulatory strategies and resolving complex issues with minimal guidance.
• Drive the preparation, planning, coordination, execution, and ongoing maintenance of regulatory submissions, ensuring quality and compliance.
• Serve as the regulatory expert on cross-functional teams, evaluating submission management processes and sharing best practices.
• Interpret existing regulations and guidance documents, building internal advocacy networks across various departments.
• Understand political processes and their impact on public policy and regulatory laws.
• Identify present and future unmet quality, regulatory, and compliance needs, generating novel approaches and creating scalable solutions.
• Contribute domain expertise to regulatory, quality, clinical, product, design, and engineering teams.
• Plan, coordinate, prepare, and execute meetings with regulatory agencies, facilitating communication and reviews.
• Analyze data from events with extended recovery times to understand root causes, collaborating with cross-functional stakeholders and vendors.
• Synthesize recurring issues across events to propose and implement fixes, driving continuous improvement initiatives.
• Partner with vendors and internal teams to pinpoint process breakdowns and drive corrective actions within end-to-end processes.
• Contribute to the population of key weekly reports and communications for executive audiences.

What You'll Bring:

Required Skills & Qualifications:

• Proficiency in registration and auditing processes.
• Exceptional communication and influence skills.
• Strong understanding of information governance.
• Demonstrated project scoping and execution capabilities.
• Expertise in regulatory compliance.
• Proven risk management abilities.
• Knowledge of standards, regulations, and reporting.
• Solid project/program management skills.
• Domain-specific knowledge and skills relevant to quality, regulatory, safety, and trust.
• Technical, clinical, and partner knowledge.
• Commitment to product excellence.
• Strong business acumen.

Preferred Skills & Qualifications:

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