Device Program Lead

Planet Pharma Group; Brussel; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

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

Mansioni

• 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.

Conoscenze

Cross-functional leadership

Regulatory compliance

Project planning

Quality systems

GMP experience

Descrizione del lavoro

Device Program Lead

Help shape the future of drug delivery systems across their full lifecycle–from first introduction through industrialisation, commercial launch and ongoing maintenance. As Device Program Lead, you’ll bring together technical experts and cross-functional partners to deliver safe, effective and compliant combination products.

Overview

You’ll join the Devices, Artwork & Packaging organisation in a senior role leading one or more device programmes. You’ll develop the programme vision, coordinate virtual project teams and manage collaboration with internal stakeholders and external partners. The role also offers opportunities to contribute as a focused expert across additional device programmes.

Key Responsibilities

• Lead the design, development, industrialisation, lifecycle management and maintenance 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 industrialisation contracts.
• Ensure compliance with medical device quality systems, GMP and applicable regulatory requirements.
• Prepare and justify design verification, design validation, process validation and commercial launch plans.
• Contribute to regulatory submissions and post-market approval obligations.
• Create and maintain the Design History File throughout the product lifecycle.
• Evaluate new devices and technologies and translate customer needs into realistic product and programme requirements.
• Protect intellectual property generated through programme activities.
• Lead, coach and influence cross-functional and matrix teams, supporting effective issue resolution and decision-making.

Must-Have

• At least 5 years’ experience in the pharmaceutical, biologics or medical device industry.
• Practical understanding of relevant standards and regulations, including ISO 13485, 21 CFR 820, 21 CFR 210/211, 21 CFR 4, ISO 14971, ICH Q9 and MDR requirements.
• Experience leading or coordinating cross-functional teams and influencing internal and external stakeholders.
• Strong planning, organisation, communication, presentation and negotiation skills.
• Ability to manage complex technical activities and drive decisions in challenging situations.

Nice-to-Have

• Operational GMP or quality experience.
• Green Belt and/or project management certification.

Bring your device-programme expertise to a role with meaningful impact across the complete product lifecycle–