Senior Director, Post Market Surveillance

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Provides strategic leadership to develop and maintain the global vision, strategic direction, and long-term plan for post market surveillance, vigilance, and regulatory compliance throughout the organization.

• Acts as the executive authority for decisions regarding post market surveillance, escalations, and regulatory engagements.

• Guarantees that globally harmonized processes, systems, procedures, and decision pathways comply with ISO 13485, FDA QSR, and EU MDR standards.

• Owns and enhances PMS processes, ensuring they align with corporate goals and regulatory requirements.

• Ensures effective complaint trending, signal detection, and escalation procedures are in place.

• Manages global vigilance reporting, including EU MIRs, FDA MDRs, Health Canada, MHRA, TGA, and PMDA.

• Leads cross-functional recall teams, ensuring global alignment across product platforms and timely resolutions.

• Maintains preparedness for global recalls and oversees crisis response governance.

• Directs the global Health Hazard Evaluation (HHE) process, ensuring scientifically sound, risk-based assessments are conducted.

• Provides executive oversight for EU MDR post market reporting deliverables, such as PSURs, PMSRs, and trend analyses.

• Collaborates with Operations, R&D, and Quality to implement systemic improvements based on data insights.

• Serves as the executive liaison with OEM partners regarding safety, quality incidents, and systemic corrective actions.

• Ensures prompt response and resolution of OEM SCARS.

• Influences senior leadership and cross-functional stakeholders with data-driven insights and strategic recommendations.

• Performs additional duties as required.

⛳️ Requirements

• A Bachelor's degree in engineering, life sciences, or a related field; an advanced degree is preferred.

• At least fifteen (15) years of experience in sales, including eleven (11) years in a leadership role related to medical device post market surveillance, vigilance, or quality functions.

• Extensive knowledge of EU MDR, FDA QSR, ISO 13485, MDSAP, and global vigilance regulations.

• Proven track record of successfully leading global teams.

• Demonstrated capability to navigate complex global processes and regulatory engagements.

• Ability to collaborate effectively across all management levels and with employees to identify and resolve issues.

• Strong ability to work as part of the Global Quality team to achieve organizational goals efficiently.

🏝️ Benefits

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

• Medical/Dental & Other Insurances (eligible the first of month after 30 days)

• Low Cost Onsite Medical Clinic

• Two (2) Onsite Cafeterias

• Employee Garden | Gardening Classes

• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

• 401K | Health Savings Account