Senior Director, Post Market Surveillance

Job not on LinkedIn

🔥 0 minutes ago

🏈 Ohio – Remote

🏈 Ohio – Remote

⏰ Full Time

🟠 Senior

👔 Director

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Merit Medical Oncology

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1987

🤝 B2B

💰 $4.2M Venture Round - Cianna Medical on 2016-10

B2B

Merit Medical Oncology is a division/specialty of Merit Medical Systems focused on devices and procedural solutions for oncologic interventions. It is part of Merit Medical Systems, a global manufacturer founded in 1987 that designs and markets proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures across cardiology, radiology, oncology, critical care and endoscopy. Merit Medical Oncology supports hospitals and physicians worldwide with products (e. g. , biopsy, embolotherapy, drainage, and other oncology-related interventional tools), clinician education and training, regulatory and product documentation, and global distribution and customer support.

📋 Description

• 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.

🏖️ 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