Apply on Employer Site

Noah Medical · 8 hours ago

VP, Regulatory & Quality

San Carlos, CA

Full-time

Hybrid

Director/Executive

$240K/yr - $295K/yr

Noah Medical is building the future of medical robotics, focusing on early diagnosis and treatment through advanced robotic platforms. The Vice President of Regulatory and Quality will ensure compliance with regulatory standards and maintain high-quality levels within the organization, overseeing regulatory affairs, quality management systems, and quality assurance initiatives.

Health CareHealth DiagnosticsMedical Device

Senior Management

Responsibilities

Stay abreast of relevant regulatory requirements, guidelines, and industry best practices

Develop and implement strategies to ensure compliance with local, national, and international regulations

Advocate for the company's regulatory and quality interests and represent the organization in regulatory discussions, audits, inspections, and quality management reviews

Ensure regulatory compliance by overseeing advertisement and promotional programs, including review and approval of marketing materials, advertising campaigns, and promotional activities in alignment with FDA regulations and international standards

Establish and maintain robust quality management systems (QMS) to support the organization's operations

Lead the development, implementation, and maintenance of quality policies, procedures, and processes

Monitor and evaluate the effectiveness of the QMS through audits, inspections, and metrics analysis

Lead Design Control program to ensure that design inputs, verification, validation, and design transfer activities meet regulatory requirements and quality standards

Develop and implement post-market surveillance strategies, including complaint handling, adverse event reporting, and corrective and preventive action (CAPA) processes, to ensure ongoing product safety and regulatory compliance

Collaborate with cross-functional teams to address quality issues and drive corrective and preventive actions

Identify and assess regulatory and quality risks associated with products, processes, and systems

Develop and implement risk management strategies for hardware and software components, including risk assessment, mitigation plans, and risk-based decision-making processes to minimize compliance and quality-related risks

Provide guidance on risk management principles and practices to relevant stakeholders

Recruit, develop, and retain a high-performing team of regulatory and quality professionals

Foster a culture of accountability, collaboration, and continuous improvement within the department

Provide leadership, guidance, and mentorship to team members to support their professional growth and development

Provide strategic regulatory/quality guidance to the leadership team in support of decision-making

Provide strategic leadership in regulatory affairs and quality assurance, develop regulatory and quality strategies aligned with business objectives, and oversee the execution of regulatory and quality plans throughout the product lifecycle

Collaborate with other functional areas, including R&D, manufacturing, supply chain, and commercial teams, to integrate regulatory and quality considerations into product development and commercialization strategies

Serve as a subject matter expert on regulatory and quality matters, providing guidance and support to cross-functional teams

Drive continuous improvement initiatives to enhance regulatory compliance and quality performance

Champion quality excellence and promote a culture of quality throughout the organization

Implement quality improvement tools and methodologies to streamline processes and optimize resource utilization

Qualification

Regulatory AffairsQuality Management SystemsQuality AssuranceRisk ManagementContinuous ImprovementRegulatory SubmissionsISO StandardsLeadershipCommunication SkillsProblem-SolvingTeam Management

Required

Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred

Extensive experience in regulatory affairs and quality management within the medical device, biotechnology, or related industries

Proven track record of successful regulatory submissions, quality audits, and continuous improvement initiatives including clearance of multiple complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software

In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO)

Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485

Excellent leadership, communication, and interpersonal skills

Strategic mindset with the ability to drive change and foster innovation

Thrives in a fast-paced, hands-on environment that is frequently changing

Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences

Exceptional problem-solving and decision-making abilities

Demonstrated experience in building, leading, and developing high-functional teams, with demonstrated success in fostering collaboration, innovation, and professional growth