HR
Program Lead - Drug Delivery
- Hiring from
- Belgium
- Work type
- Hybrid
- Posted
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Role Overview
An exciting opportunity for a Device Program Lead to join our client’s international Devices, Artwork & Packaging organisation within a highly regulated medical device environment.
The role will focus on the commercial lifecycle management and maintenance of drug delivery systems, including safety syringes and auto-injectors. This is a hands-on position requiring extensive experience in medical devices or drug delivery systems, with responsibility for managing technical activities, documentation and stakeholder coordination. Hybrid working is available, with a stronger on-site presence expected during onboarding before moving towards an approximate two-day on-site and three-day remote working pattern.
Key Duties And Responsibilities
Your duties as the Device Program Lead will be varied however the key duties and responsibilities are as follows:
An exciting opportunity for a Device Program Lead to join our client’s international Devices, Artwork & Packaging organisation within a highly regulated medical device environment.
The role will focus on the commercial lifecycle management and maintenance of drug delivery systems, including safety syringes and auto-injectors. This is a hands-on position requiring extensive experience in medical devices or drug delivery systems, with responsibility for managing technical activities, documentation and stakeholder coordination. Hybrid working is available, with a stronger on-site presence expected during onboarding before moving towards an approximate two-day on-site and three-day remote working pattern.
Key Duties And Responsibilities
Your duties as the Device Program Lead will be varied however the key duties and responsibilities are as follows:
- Lead and actively manage commercial lifecycle activities for medical devices and drug delivery systems, ensuring deliverables are completed on time and to the required quality standards.
- Manage complaints, deviations, technical investigations, change controls and CAPAs associated with on-market products.
- Maintain and update technical documentation, including Design History Files and risk management documentation.
- Coordinate technical activities across internal stakeholders and external partners, while prioritising and following up activities within the electronic Quality Management System.
- As the Device Program Lead you will communicate and report effectively to management, highlighting key priorities, risks, issues and required actions.
Role Requirements
To be successful in your application to this exciting role as the Device Program Lead we are looking to identify the following on your profile and past history:
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career"
To be successful in your application to this exciting role as the Device Program Lead we are looking to identify the following on your profile and past history:
- A Degree or higher level in a relevant field, such as medical devices, biomedical engineering, pharmaceutical sciences, quality assurance or quality management.
- Extensive experience in medical devices or drug delivery systems, with proven commercial lifecycle management expertise and hands-on involvement in complaints, deviations, technical investigations, change controls and CAPAs.
- Extensive experience managing technical documentation, particularly Design History Files and risk management documentation, alongside practical knowledge of relevant regulatory and quality frameworks such as ISO 13485, ISO 14971, MDR, 21 CFR 820, 21 CFR 210/211, 21 CFR Part 4 and ICH Q9.
- Strong organisational, communication and stakeholder management skills, with the ability to prioritise a significant workload, work effectively with internal and external partners, become autonomous quickly and contribute positively within an international, team-oriented environment. Fluency in English is essential; French, operational GMP or Quality experience, project management or Green Belt certification, and familiarity with electronic Quality Management Systems would be advantageous.
- Take ownership of commercially important lifecycle management activities across a range of medical devices and drug delivery systems.
- Join an international, collaborative Device Program Leadership team with opportunities to build strong relationships across functions and external partnerships.
- Benefit from a hybrid working model, with flexibility increasing following the onboarding and knowledge-transfer period.
- Gain a renewable assignment with a mid- to long-term perspective and the opportunity to make a tangible contribution in a highly regulated environment.
- Work in a hands-on senior position where your technical expertise, organisation and leadership of activities will be highly valued.
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career"
