Senior Device Program Lead - Drug Delivery (Hybrid)

Planet Pharma; Waterloo; Hybrid; EUR 90.000 - 140.000; Vollzeit

Zusammenfassung

Planet Pharma in Belgium is seeking a seasoned Device Program Lead to drive the development and delivery of drug-device combination products across a diverse portfolio. You will coordinate across engineering, quality, regulatory and manufacturing in a global, collaborative setting to ensure programs are delivered on time, within budget and in line with regulatory expectations.

You will lead programs from concept through commercialization, guide risk management and design control activities,

Qualifikationen

• Proven experience leading medical device, drug delivery or combination product development programs.
• Strong understanding of medical device product development processes and design control requirements.
• Experience working within highly regulated healthcare environments.
• Knowledge of ISO 13485 and ISO 14971 regulatory standards.

Aufgaben

• Lead end-to-end device development programs from concept through launch and lifecycle management.
• Drive program strategy, planning, execution and governance across multiple stakeholders and external partners.
• Coordinate multidisciplinary teams spanning engineering, manufacturing, quality, regulatory affairs and supply chain functions.
• Manage technical deliverables, timelines, budgets and resources to ensure successful outcomes.
• Support design control activities and ensure documentation is maintained throughout the product lifecycle.
• Provide technical leadership during development, scale-up and commercialization phases.

Kenntnisse

Medical device development

Project management

Cross-functional leadership

Regulatory knowledge

ISO 13485 knowledge

Lean Six Sigma

Jobbeschreibung

Planet Pharma in Belgium is seeking a seasoned Device Program Lead to drive the development and delivery of drug-device combination products across a diverse portfolio. You will coordinate across engineering, quality, regulatory and manufacturing in a global, collaborative setting to ensure programs are delivered on time, within budget and in line with regulatory expectations.

You will lead programs from concept through commercialization, guide risk management and design control activities,