Associate Director/Director, Global Product Surveillance

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!