Senior Director, Post Market Surveillance

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.