Drug Device Combination Expert

We are recruiting a Drug Device Combination Expert to join a leading Pharmaceutical company based in the Walloon Region, Belgium. As the Drug Device Combination Expert, you will play a strategic and hands-on role in shaping the development, industrialisation, and documentation of combination products, with a strong emphasis on autoinjector platforms.

This is an initial mission until the end of December 2026, with possible extension and can offer hybrid working.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Drug Device Combination Expert will be varied; however, the key duties and responsibilities are as follows:

1. As the Drug Device Combination Expert, you will lead the risk management workstream for the autoinjector drug–device combination products platform project, covering activities from concept through commercialisation.

2. As the Drug Device Combination Expert, you will ensure compliance with relevant standards and regulations, including ISO 13485, ISO 14971, ICH Q9/Q8/Q10/Q12, 21 CFR Part 4, EU MDR Article 117 and associated global combination product regulations.

3. As the Drug Device Combination Expert, you will collaborate closely with the platform project manager and cross-functional teams to maintain alignment with project timelines, design control expectations, and internal quality system processes.

4. As the Drug Device Combination Expert, you will provide expert guidance on component selection, human factors engineering, verification & validation (V&V), and device reliability.

ROLE REQUIREMENTS:

To be successful in your application to this exciting role as Drug Device Combination Expert, we are looking to identify the following on your profile and past history:

1. Relevant degree in a scientific or engineering discipline.

2. Extensive industry experience in drug–device combination product development, ideally with strong exposure to autoinjectors or parenteral delivery platforms.

3. A working knowledge and practical experience with medical device and combination product documentation, including DHF, RMF, design control, and regulatory files.

Key Words: Drug–Device Combination Product Development / Autoinjector Platforms / Risk Management / ISO 13485 / ISO 14971 / ICH Q9 / ICH Q8 / ICH Q10 / ICH Q12 / 21 CFR Part 4 / EU MDR Article 117 / Medical Device Documentation / Pharmaceutical Industry

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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.