Associate Director/Director, Global Product Surveillance (Security)

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!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Quality Systems/Customer Satisfaction