Senior Manager, Post-Market Surveillance
Merative
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Lead the designated complaint handling unit (DCHU) for Merge Healthcare’s medical imaging portfolio and manage the post market surveillance process
- Establish, implement, and maintain efficient and effective processes and supporting tools for complaint handling and post market surveillance
- Establish and maintain complete and accurate complaint files and other associated records
- Ensure prompt escalation of product safety concerns for investigation and event reporting to applicable regulatory authorities
- Define, collect, and analyze metrics and key performance indicators to monitor complaint handling effectiveness and provide inputs to Management Reviews
- Perform analysis of complaint trends to identify product quality and safety concerns and provide feedback to Product Management, Development, Customer Success, Quality Engineering, and Regulatory Affairs
- Collaborate with Regulatory Affairs to perform post market surveillance activities, including establishing post-market surveillance plans and reports and performing data analysis
- Ensure Post Market Surveillance feedback is provided to cross-functional teams
- Collaborate with cross-functional stakeholders to drive root cause analysis and implement corrective and preventive actions
- Escalate significant risks, issues, or concerns to executive leadership
- Participate in internal and external audits and inspections as necessary
- Provide oversight for development and improvement of quality programs, systems, processes, and procedures to ensure compliance with applicable regulation and standards
- Lead and mentor a high-performing team of direct reports, establish performance expectations, provide feedback, coaching, and recognition
- Ensure adequate resources are identified and allocated to achieve objectives and escalate issues to executive management
Requirements
- Bachelor’s degree in a scientific or technical discipline required, or equivalent experience
- Minimum of 10 years of medical device or life sciences industry experience
- At least 5 years experience in a leadership role
- Minimum 5 years in medical device industry, specifically Complaint Handling and Post Market Surveillance
- Experience supporting or participating in internal and external Quality Management System audits and regulatory inspections
- In-depth understanding of global medical device regulations, including 21 CFR Part 820, SOR/98-282 Canada, and Medical Device Regulation 2017/745 EU
- Specific experience with software medical devices (SaMD and SiMD)
- Proficiency with Microsoft Word, Excel and PowerPoint required
- Prior people management experience required
- Strong technical acumen with ability to understand complex medical imaging software systems
- Ability to work independently with minimal supervision
- Ability to influence change and champion initiatives
- Excellent interpersonal, communication, technical writing, and editing skills
- Effective research, analytical, and critical thinking skills
- Self awareness and emotional intelligence skills
- Flexible to multiple time zones