Lumicity

Compensation

Full Description

Key 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. Qualifications • Bachelor’s degree required in engineering, life sciences, or a related field • Advanced degree (MS, PhD, JD) strongly preferred • 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