Boston Scientific Manager PKG Eng Heredia 

Costa Rica, Heredia 

731629645

Costa Rica-Heredia

Hybrid Roles:

About the role:

This role leads efforts that facilitate and manage the compliance of product labeling with regulations, standards, and business requirements. This includes management product sustaining engineering activities for pre- and post-marketed products through the product’s life cycle. The individual will manage and develop a team that works across functions to drive labeling development from Design Freeze through retirement.

Responsibilities include:

• Monitor and train the Labeling team. Guide, coach, direct, and develop direct reports. Perform mid-year and annual performance reviews and provide continuous feedback to direct reports.
• Engage with franchises and represent the Labeling function to develop strategies, project plans, and execution of project plans to meet franchise development needs.
• Ensure the safety, quality, and compliance of launched product labeling by working with associated sustaining functions including Regulatory Affairs, Quality, Packaging, and Operations.
• Identifies and resolves all issues related to product labeling and required changes.
• Provide guidance and approval regarding labeling change strategies and approaches and implementation processes.
• Manage (process and system) business partners involved in the labeling review and approval process.
• Mediate and drive consensus for labeling content development when needed.
• Reviews, provides feedback, and approves labeling and packaging design documents. If deviations from packaging and labeling procedures and policies are warranted, communicate and escalate appropriately.
• Attend cross-functional business team meetings (strategy, scope, and implementation). Be the stakeholder for Packaging and Labeling on cross-functional teams. Escalate topics as needed.
• Lead change management communication across the business.
• Manage development, monitoring, and publishing of departmental operational metrics.
• Drives the development and continuous improvement of department tools and methodologies.
• Determines project staff assignments and schedules work to meet completion dates and project deliverables.
• Establishes cross-functional team relationships.

What we're looking for

Bachelors, Licentiate or master’s degree in engineering or related disciplines with 7-9 years of related work experience. Previous supervisory experience preferred. MUST have experience within the Medical Device industry working with Packaging R&D or Sustaining Engineering activities. English Level: 90%, Please submit Resume in English.

Management Requirements

• Lead a team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitor and ensure compliance with company policies and procedures

Quality System Requirements

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.