Medical Device Program Lead

Device Program Lead

Location: Remote (EU only)

Engagement Status: Contract

Overview

We are supporting the search for a Device Program Lead to play a key role in the design, development and industrialisation of drug delivery systems across the product lifecycle. Working within a global Devices, Artwork & Packaging environment, this position will lead device programmes from new product introduction through lifecycle management and ongoing maintenance. The role offers the opportunity to work across complex drug-device combination products, collaborating with technical, quality, regulatory and manufacturing stakeholders to ensure solutions meet medical device and GMP requirements.

Requirements

• Lead technical activities across the development, industrialisation, lifecycle management and maintenance of drug delivery systems.
• Lead cross-functional programme teams and manage relationships with internal stakeholders and external partners.
• Oversee technical project activities, including planning, resources, budgets and potentially supplier and industrialisation agreements.
• Support design verification, design validation, process validation, commercial launch planning and regulatory submissions.
• Coordinate lifecycle management activities for on-market medical devices and maintain technical quality and documentation.

Hard Skills

• 5+ years of experience within the pharmaceutical, biologics or medical device industry.
• Practical understanding of ISO 13485, 21 CFR 820, 21 CFR 210/211, 21 CFR Part 4, ISO 14971, ICH Q9 and MDR requirements.
• Experience with medical device development, industrialisation and lifecycle management.
• Understanding of Design History Files, design verification and validation, process validation and regulatory submissions.
• Experience working within medical device Quality Management Systems and GMP-regulated environments.

Soft Skills

• Strong leadership skills with the ability to coordinate and influence cross-functional and matrix teams.
• Excellent stakeholder management and negotiation skills across internal teams and external partners.
• Strong planning and organisational skills with the ability to drive issue resolution and decision-making.
• Excellent interpersonal, verbal and written communication skills.
• Proactive, analytical and solution-oriented approach with the ability to identify risks and drive effective corrective actions.

Qualifications

• Master’s degree required for the role.
• 5+ years of relevant pharmaceutical, biologics or medical device industry experience.
• Operational GMP or quality experience would be a distinct advantage.
• Green Belt and/or Project Management certification would be advantageous.
• Experience working within cross-functional and cross-cultural teams in a regulated environment is highly desirable.