Senior Director, Post Market Surveillance
Work Shift: DAYWork Schedule: Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. ESSENTIAL FUNCTIONS PERFORMED 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. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS Lifting -- Not to exceed 50 lbs. -- local practice may apply. Writing Sitting Standing Bending Visual acuity Color perception Depth perception Reading Field of vision/peripheral SUMMARY OF MINIMUM QUALIFICATIONS
- 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.
COMPETENCIES
- Leadership
- Oral and written communication
- Interpersonal skills
- Data analysis
- Problem solving
- Project management
- Analytical Skills
COMMENTS Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure. As an eligible Merit employee, you can expect the following:
- 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
To see more on our culture, go to www.merit.com/careers. Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.