Senior Device Program Lead: Shape Drug-Delivery Systems

Planet Pharma; Brussel; On-site; EUR 90,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a Device Program Lead to shape strategy across the lifecycle of drug delivery systems. You will lead cross-functional teams, coordinate internal and external partners, and ensure alignment with ISO 13485, MDR, and GMP requirements.

The role emphasizes stakeholder management, project planning, and managing budgets and contracts, with a focus on delivering compliant, safe, and effective combination products.

Qualifications

• Must have 5+ years in pharma/biotech or medical device industry.
• Strong understanding of ISO 13485, MDR, GMP, and regulatory affairs.

Responsibilities

• Lead design, development, and lifecycle management of drug delivery systems.
• Coordinate technical activities across internal teams, manufacturing, quality, regulatory affairs and external partners.
• Manage project plans, budgets, resources, supplier agreements and contracts.
• Ensure compliance with medical device quality systems, GMP and regulatory requirements.
• Prepare and justify design verification, design validation, process validation and commercial launch plans.
• Contribute to regulatory submissions and post-market obligations.
• Create and maintain the Design History File throughout the product lifecycle.
• Evaluate new devices and technologies and translate customer needs into programme requirements.
• Protect intellectual property generated through programme activities.
• Lead, coach and influence cross-functional and matrix teams, supporting issue resolution and decision-making.

Skills

Cross-functional leadership

Regulatory compliance

Project planning

Quality systems

GMP experience

Job description

Planet Pharma is seeking a Device Program Lead to shape strategy across the lifecycle of drug delivery systems. You will lead cross-functional teams, coordinate internal and external partners, and ensure alignment with ISO 13485, MDR, and GMP requirements.

The role emphasizes stakeholder management, project planning, and managing budgets and contracts, with a focus on delivering compliant, safe, and effective combination products.