Senior Project Manager

About the role

Freudenberg Medical is seeking a Senior Project Manager to lead complex medical device and pharmaceutical projects from concept through volume production. Based in Alajuela, you will act as the primary liaison between customers, clinicians, and internal stakeholders, ensuring projects meet scope, schedule, cost, and quality expectations.

Key responsibilities

• Build and lead cross‑functional internal teams and manage external vendors, suppliers, and contractors.
• Serve as the main point of contact for customers and key stakeholders, providing regular updates and managing expectations.
• Oversee project budgeting, internal billing, and transfer cost of goods sold (TCOGS) in collaboration with Finance and Operations.
• Evaluate new business opportunities, support quote generation, and work with Sales to close strategic deals.
• Allocate resources, lead “make or buy” decisions, and maintain comprehensive project documentation for audit readiness.
• Manage multiple high‑risk or strategic projects, ensuring compliance with PMBOK, ISO, FDA, MDR, Health Canada, PMDA, and GMP requirements.
• Supervise design history files, device master records, risk analyses, and validation protocols (IQ/OQ/PQ).

Required profile

• Proven experience managing large‑scale, regulated medical device or pharmaceutical projects.
• Strong ability to navigate complex stakeholder environments and resolve resource constraints.
• Excellent communication skills and a proactive risk‑management mindset.

Required skills

• PMBOK methodology
• ISO standards (e.g., ISO 13485)
• GMP regulations
• FDA, MDR, Health Canada, and PMDA regulatory frameworks
• IQ/OQ/PQ validation processes

What we offer

• Diverse and inclusive work environment
• Opportunities for international mobility
• Commitment to sustainability and social projects
• Corporate events and team celebrations
• Safe and stable workplace