Vice President, Regulatory Affairs and Quality Assurance About the Company Innovative AI company providing life-saving technology to healthcare organizations
Industry
Medical Devices
Type
Privately Held, VC-backed
Founded
2011
Employees
201-500
Funding
$76-$100 million
Categories ElectronicsManufacturingBiotechnologyAcademic ResearchLaboratory ServicesMedicineArtificial Intelligence (AI)Health CareHealth DiagnosticsMedical DeviceMedical Care Specialties MedicalHealthcareAIStrokeAneurysmand PE About the Role The Company is seeking a Vice President of Regulatory Affairs and Quality Assurance to lead the strategic and operational management of quality and regulatory activities. The successful candidate will be responsible for developing and maintaining the company's regulatory affairs and quality assurance strategy and programs, ensuring compliance with global regulatory requirements, and driving a culture of quality throughout the organization. This role involves establishing and monitoring quality standards, metrics, and objectives, as well as leading process improvements to support the company's growth objectives. The VP will also be the key contact for building and managing relationships with regulatory agencies and standards groups, and will be expected to have a commercial focus in the application of regulatory requirements.
Candidates for the VP RA/QA position at the company should have a Bachelor's degree in a relevant engineering or scientific discipline, with an advanced degree strongly preferred, and at least 15 years of progressive experience in leading RA/QA, with a primary focus on QA and a background in SaMD, SaaS, SWMD models, and software-focused quality systems. The role requires a leader who is analytical, results-oriented, and process-driven, with a passion for quality and regulatory compliance. Excellent knowledge of US and global regulatory frameworks, direct experience with submissions, and a proven track record of leading engagements with regulatory agencies are essential. The ideal candidate will have outstanding communication skills, strong problem-solving abilities, and a demonstrated capacity to manage and prioritize multiple projects and teams.
Hiring Manager Title
Regulatory Affairs Project Manager
Travel Percent
20%
Functions General ManagementStrategyOperations