Lumicity · 17 hours ago
Vice President of Regulatory Affairs
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
15+ years expLumicity is a company focused on regulatory affairs in the medical device industry, and they are seeking a Vice President of Regulatory Affairs. This role involves defining global regulatory strategies, providing guidance to leadership, and overseeing regulatory submissions and compliance.
Human ResourcesRecruitingStaffing Agency
Hiring Manager
Greye Dunn
Responsibilities
Define and execute global regulatory strategies for medical devices across the full product lifecycle, from early development through commercialization and post-market activities
Provide strategic regulatory guidance to executive leadership on risk, timelines, and market access opportunities
Serve as the regulatory subject-matter expert for corporate decision-making, M&A activities, and product portfolio planning
Oversee preparation, submission, and approval of regulatory filings, including but not limited to:
FDA submissions (510(k), PMA, De Novo, IDE)
EU MDR/IVDR technical documentation and CE marking
International submissions (e.g., Canada, Japan, China, Australia, LATAM)
Ensure consistency and quality across all regulatory submissions and communications
Act as the primary point of contact with regulatory authorities and notified bodies
Lead and participate in regulatory meetings, audits, inspections, and negotiations
Proactively manage regulatory risks and responses to agency inquiries or enforcement actions
Ensure ongoing compliance with applicable regulations and standards (e.g., FDA QSR, ISO 13485, EU MDR, MDSAP)
Provide regulatory oversight for post-market surveillance, vigilance reporting, field actions, and product changes
Collaborate with Quality to ensure regulatory alignment across audits, CAPAs, and inspections
Partner with R&D and Clinical teams to ensure regulatory requirements are integrated into product design and development
Work with Manufacturing and Supply Chain to support regulatory compliance related to site changes, process improvements, and scaling
Support Commercial teams with regulatory input for labeling, claims, and market expansion
Build, lead, and mentor a high-performing regulatory affairs organization
Establish scalable regulatory processes and infrastructure to support company growth
Foster a culture of regulatory excellence, accountability, and collaboration
Qualification
Required
Bachelor's degree required in engineering, life sciences, or a related field
15+ years of regulatory affairs experience within the medical device industry
Proven leadership experience managing global regulatory teams
Demonstrated success leading FDA and international regulatory submissions
Deep knowledge of FDA regulations, EU MDR, and international regulatory frameworks
Experience supporting both pre-market and post-market regulatory activities
Strategic thinker with strong business acumen
Excellent communication and executive presence
Ability to influence cross-functional stakeholders at all levels
Strong problem-solving and risk-management skills
Comfortable operating in fast-paced, evolving environments
Preferred
Advanced degree (MS, PhD, JD) strongly preferred
Company
Lumicity
Lumicity is a technical staffing agency that provides staffing solutions for engineering, life sciences, technology, and energy industries.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase