Senior Director, Post Market Surveillance

Darum lohnt es sich

Responsibilities • Provides leadership to establish and sustain the global vision, strategic direction, and long-term roadmap for post market surveillance, vigilance, and regulatory compliance across the organization. • Serves as the executive authority for post market surveillance decisions, escalations, and regulatory interactions. • Ensures globally harmonized processes, systems, procedures, and decision pathways are aligned with ISO 13485, FDA QSR, and EU MDR. • Owns and evolves PMS processes, ensuring alignment with corporate objectives and regulatory expectations. • Ensures robust complaint trending, signal detection, and escalation processes. • Oversees global vigilance reporting (EU MIRs, FDA MDRs, Health Canada, MHRA, TGA, PMDA). • Leads cross‑functional recall team(s) and ensures global alignment across product platforms and ensures timely closure. • Maintains global recall readiness and crisis response governance. • Directs the global HHE process, ensuring scientifically sound, risk‑based assessments. • Provides executive oversight for EU MDR post market reporting deliverables, including PSURs, PMSRs, and trend analyses. • Partners with Operations, R&D, and Quality to drive systemic improvements based on data insights. • Serves as the executive interface with OEM partners on safety, quality events, and systemic corrective actions. • Ensures timely response and closure of OEM SCARS. • Influences senior leadership and cross functional stakeholders through data driven insights and strategic recommendations. • Performs other duties, as required.

Requirements • Education equivalent to a Bachelor’s degree in engineering, life sciences, or related field; advanced degree preferred. • A minimum of fifteen (15) years of experience in sales with eleven (11) years in a leadership position in medical device post market surveillance, vigilance, or quality roles. • Deep expertise in EU MDR, FDA QSR, ISO 13485, MDSAP, and global vigilance requirements. • Demonstrated success leading global teams. • Proven ability to manage complex global processes and regulatory interactions. • Ability to work across all levels of management and employees to identify and resolve issues. • Ability to work well as part of Global Quality team to accomplish organizational objectives effectively.