Senior Manager @ Merative

Medical, Clinical & Veterinary (1)

Join a team dedicated to supporting the crucial mission of improving health outcomes.

At Merative, you can apply your skills – and grow new ones – with colleagues who have deep expertise in health and technology. Merative provides data, analytics and software for the health industry. Our clients include providers, health plans, employers, life sciences companies and governments around the world. With industry-leading products and focused innovation, we help customers improve decision-making and performance so that together, we drive real progress in health. Learn more at merative.com

Merge medical imaging solutions, offered by Merative, combine intelligent, scalable imaging workflow tools with deep and broad expertise to help healthcare organizations improve their confidence in patient outcomes and optimize care delivery.

The Sr Manager, Post Market Surveillance is accountable for leading the designated complaint handling unit (DCHU) for Merge Healthcare’s medical imaging portfolio and for managing the post market surveillance process. This is a critical leadership role with responsibility for managing a specialist team focused on the timely and accurate intake, investigation, documentation, and resolution of product complaints in accordance with applicable regulations and industry standards. This role requires strong collaboration and communication with cross-functional stakeholders at all levels of the organization, including product management, development, customer support, implementation services, quality engineering, regulatory affairs, and legal.

Responsibilities:

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

Establishes, implements, and maintainsan efficient and effective processesand 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 andprovides 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 establishingpost-market surveillance plans and reports, and performing data analysis, in accordance withapplicable 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 Handlingand 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

It is the policy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Merative will provide reasonable accommodations for qualified individuals with disabilities.

Merative participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

Senior Manager

Post Market Surveillance

Merative

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