Senior Director, Post Market Surveillance

Merit Medical Oncology

Senior Director of Post Market Surveillance at Merit Medical. Leading strategies for regulatory compliance in medical devices across global markets.

Posted 6/17/2026full-timeRemote • Ohio • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

post market surveillanceregulatory compliancecomplaint trendingsignal detectionrisk-based assessmentsdata insightsglobal vigilance reportingtrend analysessystemic improvementsexecutive oversight

Soft Skills

leadershipcross-functional collaborationstrategic recommendationsinfluencing senior leadershipproblem-solvingcommunicationteamworkorganizational objectivesstakeholder engagementcrisis response governance