Quality, Regulatory, Safety and Trust Specialist

Aquent, a global leader in talent solutions, is proud to partner 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.

Step into a pivotal role where your expertise will directly influence the integrity and efficiency of critical operations for groundbreaking technologies. 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, leaving a lasting mark on the future of the industry.

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.

Required Skills & 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.

Preferred Skills & 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.