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Associate Director/Director, Global Product Surveillance

Merz Aesthetics
$118,955 - $176,044 a year
United States
Full time
1 week ago
Associate Director/Director, Global Product Surveillance
Category
Other
Job Id
ASSOC004145
Job Type
Full Time
Posted Date
06/10/2025

Keys Responsibilities:

Global Strategy & Program:

  • Establish and maintain global strategy and program for Product Surveillance.
  • Lead product surveillance team ensuring that appropriate processes are established and followed. Responsible for ensuring records are timely and accurate.
  • Establish and maintain departmental metrics and reporting. Support 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.
  • Provides strategic direction to internal and external partners regarding integration of Post Market Processes into Design and Change Control systems

Functional Leadership:

  • Development of highly competent staff and future leadership.
  • Engagement with senior/executive leadership including knowledge transfer and strategic guidance, including communication regarding most current trends and data analysis regarding product surveillance.
  • Allocates human resources and selects, acquires, and deploys appropriate methodologies to fulfill near term goals and commitments while ensuring sustainable quality performance.
  • Motivates and leads their organization to achieve business objectives.

State of the Art:

  • Evaluate and Implement New Technologies and Improve Operational Efficiencies.
  • Secure firm knowledge of business processes, global regulatory requirements and support on-going system use and training of users.
  • Actively identify and execute process improvements in alignment with global stakeholders.
  • Research and identify enabling solutions, best practices, and technologies to proactively address customer needs and regulatory requirements.
  • Continuously evaluate policies, procedures, and training to ensure continued compliance with company standards, current industry best practices and current regulatory requirements.

Trending/CAPA:

  • Leads effective complaint management by ensuring appropriate complaint investigations are conducted and effective trending is utilized to ensure safety and effectiveness of Merz products.
  • Trends data and monitors trends for possible systemic issues that may be impacting one or more products and assigns appropriate corrective actions internal and external stakeholders to mitigate issues.
  • Reviews recommended CAPAs, as part of complaint closure process, and determines their appropriateness for the Root Cause(s) that were identified.
  • Assign tasks to team members to ensure appropriate issue escalation occurs related to any quality or compliance issues.

eQMS:

  • Manages the implementation of any revisions or new implementation of new Enterprise Quality Management Systems for Complaint Handling and Adverse Event Reporting.

Inspections and Audtis:

  • Support continued company certification to the appropriate Quality Management System Standards and Regulations and assist with all related audits and inspections as required.

Organizational Support:

  • Maintain positive working relationships and ensure appropriate representatives from affected departments are involved.

Budget:

  • Manage Departmental Budgets in accordance with approved targets

Minimum Requirements:

  • Bachelor's Degree. Required
  • 10(AD)/ 15 (D) years minimum in Pharmaceutical or Medical Device Industry. Required
  • Proven leadership in managing cross-functional teams and driving product quality improvements. Required

Preferred Qualifications:

  • Master's Degree. Preferred
  • 2 (AD) 5(D) years minimum in a leadership role. Preferred

Technical & Functional Skills:

  • In-depth understanding of medical device regulations: FDA 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR. Required
  • Engineering principles and methodologies related to product design, manufacturing, and post-market surveillance. Required
  • Quality management systems and risk assessments. Required
  • Industry trends and advancements in medical device technology. Required
  • Strong analytical, Statistical, technical and general problem-solving skills. RequiredAbility to manage priorities in a fast-paced environment. Required
    Exceptional leadership capabilities to manage and mentor teams. Required
  • Ability to work effectively in a global, matrix environment. Required
  • Ability to work independently as well as direct and control the efforts of Direct Reports as applicable. Required
  • Strong interpersonal skills and ability to collaborate effectively with various technical area experts. Required

Benefits:

  • Comprehensive Medical, Dental, and Vision plans
  • 20 days of Paid Time Off
  • 15 paid holidays
  • Paid Sick Leave
  • Paid Parental Leave
  • 401(k)
  • Employee bonuses
  • And more!

Your benefits and PTO start the date you're hired with no waiting period!

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