Device Program Lead

Location: Remote (EU only)

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 SkillsStrong 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.