Responsibilities:

• Provides leadership, expertise, and guidance for the interpretation of applicable regulations and industry standards for complaint handling and post market surveillance to Merge Healthcare.

• Establishes, implements, and maintains an efficient and effective processes and supporting tools for complaint handling and post market surveillance.

• Establishes and maintains complete and accurate complaint files and other associated records.

• Ensures the prompt escalation of product safety concerns for investigation and event reporting to applicable regulatory authorities.

• Defines, collects, and analyzes metrics and key performance indicators to monitor the effectiveness of the complaint handling process, and provides inputs to Management Reviews.

• Performs analysis of complaint trends to identify product quality and safety concerns and provides feedback to cross-functional teams including Product Management, Development, Customer Success, Quality Engineering, and Regulatory Affairs as necessary.

• Collaborates with Regulatory Affairs to perform post market surveillance activities, including establishing post-market surveillance plans and reports, and performing data analysis, in accordance with applicable regulations and industry standards.

• Ensures that Post Market Surveillance feedback is provided to cross-functional teams including Product Management, Development, Customer Support, Quality Engineering, and Regulatory Affairs.

• Collaborates with cross-functional stakeholders to drive root cause analysis and to implement corrective and preventive actions, as required.

• Escalates any significant risks, issues, or concerns to executive leadership.

• Participates in internal and external audits and inspections, as necessary.

• Provides oversight for the development and improvement of quality programs, systems, processes, and procedures to ensure compliance with applicable regulation and standards.

• Collaborates with cross-functional business and functional leaders to drive initiatives to ensure the ongoing compliance of the QMS with applicable regulations.

• Leads and mentors a high-performing team of direct reports, fostering a culture of collaboration and continuous learning.

• Establishes clear performance expectations and goals for team members, providing regular feedback, coaching, and recognition.

Ensures adequate resources are identified and allocated to achieve objectives; escalates issues or concerns to executive management.

Core Competencies:

• Strong technical acumen, with the ability to understand complex medical imaging software systems.

• Ability to work independently with minimal supervision in a team setting to meet defined objectives.

• Ability to influence change and champion initiatives drive change in the organization.

• Excellent interpersonal, communication, and collaboration skills.

• Proficiency with Microsoft Word, Excel and PowerPoint required.

• Effective research, analytical, and critical thinking skills.

• Excellent written and oral communication, technical writing and editing skill to effectively communicate with all levels of the organization and regulatory authorities.

Technical Skills:

• In-depth understanding of global medical device regulations, including

• 21 CFR Part 820 US Quality Management System Regulation

• SOR/98-282 Canada Medical Device Regulation

• 2017/745 EU Medical Device Regulation

• Specific experience with software medical devices (SaMD and SiMD)

Supervisory Skills, (if applicable):

• Excellent supervision and leadership skills

• Prior people management experience required

• Self awareness and emotional intelligence skills

Qualifications Required:

Education Requirements:

• Bachelor’s degree in a scientific or technical discipline required, or equivalent experience.

Experience

• Minimum of 10 years of medical device or life sciences industry experience, with 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.

Work Environment

The work environment characteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Office environment, or remote work from home

• Travel: Up to 10%

• Flexible to multiple time zones