Associate Manager, Product Surveillance

Merz North America, Inc in; Racine (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Merz North America Inc. seeks an Associate Manager, Product Surveillance to lead the complaint process and oversee post-market surveillance activities. You will coordinate with Product Safety, manage investigations, and ensure compliance with regulatory requirements.

The role requires 2+ years in quality within medical devices or regulated industries, strong leadership, and excellent communication skills to interact across teams and with customers.

Qualifications

• Bachelor's degree required.
• 2+ years quality experience in medical device/pharma or regulated industry.
• Experience with post-market surveillance and complaint handling.
• Supervisor or lead experience preferred.
• Familiarity with ISO 13485 and FDA QSR regulations.

Responsibilities

• Serve as stream lead for all aspects of the complaint process.
• Coordinate with Global Product Safety for patient-related complaints.
• Lead post-market initiatives including PSUR data.
• Lead risk management activities and data review.
• Review, approve, and close complaints per SOPs.
• Manage training program and deliver training.
• Maintain departmental metrics and reporting; analyze complaint trends.
• Act as escalation point for commercial and customer relations.
• Develop corrective actions from complex problems.

Skills

ISO 13485

FDA QSR

NCR/CAPA

GMPs

Regulatory awareness

Leadership

Time management

Communication

Problem solving

Quality terminology

Education

Bachelor's Degree

Tools

Quality Management Software

MS Office

Adobe software

Job description

Associate Manager, Product Surveillance (Finance)

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

The Associate Manager, Product Surveillance is responsible for providing tactical and strategic leadership for the Product Surveillance Associates for both technical and safety related complaints. Day-to-day activities include coordination, management and review of Complaints. Perform and/or assist with tasks required to oversee the proper operation and monitoring of Complaints as it pertains to Good Documentation Practices and Local and Global Regulations. Oversee and/or assist with tasks related to the activities associated with operation of Merz North America Inc. Quality System and as directed.

Manage the product surveillance staff including interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Product Surveillance Activities

• Support team by acting as a stream lead for all aspects of the complaint process.
• Coordinate with Global Product Safety to evaluate and investigate patient-related complaints. Document consistent and compliant safety and reporting assessments.
• Lead post market initiatives including compiling and assessing data for PSUR and other reports.
• Lead risk management activities including review and coordination of post market data.
• Review, approve, and close complaints in accordance with applicable SOP(s).
• Manage the training program by developing, coordinating, and delivering training.
• Maintain and update departmental metrics and reporting. Conduct statistical analysis of complaint trends, make conclusions, and drive actions including implementation of product updates or changes based on Complaint data.
• Serve as the point of escalation and Quality Business Partner for commercial and customer relationships related to the complaint handling process.
• Develop solutions to a variety of complex problems and identify corrective actions.

Process Improvement Initiatives

• Proactively identify and implement operational changes to improve efficiencies in all aspects of complaint handling.
• Drive continuous improvement initiatives / projects in Product Surveillance as well as items that arise as a result of complaint data.
• Support/Conduct investigations associated with product deviations, product non-conformances, CAPAs, scrap, and rework. Analyze the data for the reasons of Quality Improvement and reporting.
• Originate, review, and approve internal operating procedures and specifications through the Document Change process.
• Support/Lead the development, verification, and validation of product changes and the introduction of new products as it relates to post market surveillance.

Compliance Initiatives

• Lead internal quality system audits. Support and participate in external quality system audits.
• Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
• Submit MDRs and Vigilance Reports according to regulatory timelines.
• Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.

Leadership Responsibilities

• Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company.
• Clearly define roles and responsibilities while holding members accountable for their performance.
• Develop talent and skills of individual team members
• Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.

Minimum Qualifications

Bachelor's Degree

Work Experience:

Required: 2+ years: Quality experience in Medical Device, Pharmaceutical and/or equivalent regulated industry

Preferred:

• Experience with post market surveillance and complaint handling.
• Supervisor or Lead Experience

Knowledge, Skills, Abilities - Technical & Functional

Required:

• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Strong technical and general problem-solving skills; experience with NCR/CAPA processes
• Medical and/or scientific terminology
• Professional phone etiquette with the ability to appropriately handle sensitive information.
• Proficient in Microsoft Office Suite, Adobe, and Quality System Management Software.
• Highly organized with strong attention to detail.
• Highly effective communication skills including written and verbal.
• Proven leadership skills with the ability to manage and direct teams and projects, ensuring successful outcomes and effective collaboration.
• Ability to work with company staff and communicate effectively throughout the organization.
• Strong time management skills with proven ability to prioritize and manage multiple records/reports simultaneously.