Expert in Drug–Device Combination Product Development
Solliciteren
Plaats
BrusselsBelgië
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-03-06Online to:
2026-05-05EUR 15.00 HOUR
Expert in Drug–Device Combination Product Development
- Planet Pharma
- België
- 18 uren geleden
A leading international life sciences organization is seeking a highly experienced
Senior Expert in Drug–Device Combination Product Development , with a strong focus on
autoinjector platforms . This is a strategic and hands-on role within a transversal device team, supporting the development, industrialization, and documentation of patient-centric combination products across multiple programs.
Key Responsibilities Lead the
risk management workstream
for an autoinjector combination product platform from concept through commercialization Ensure compliance with global standards and regulations including
ISO 13485, ISO 14971, ICH Q9/Q8/Q10/Q12, 21 CFR Part 4, EU MDR Article 117 Partner closely with cross-functional stakeholders to align with design control and quality system expectations Support evaluation and selection of
documentation and development software tools Provide expert input on
component selection, human factors, V&V, and device reliability Prepare, review, and approve key device documentation (DHF, RMF, usability files, regulatory submissions) Contribute to continuous improvement of combination product development processes
Required Experience & Skills 15+ years
in drug–device combination product development (autoinjector experience strongly preferred) Proven expertise in
design control, risk management, DHF/RMF, technical and regulatory documentation Strong knowledge of relevant international standards and regulatory frameworks Fluent English required;
French is a strong advantage Comfortable working in a global matrix environment with external partners Strong analytical mindset, communication, and cross-functional influence
Nice to Have Experience with injection systems (pen injectors, safety syringes, on-body delivery) Familiarity with documentation/data integrity tools Knowledge of
IEC 62366
(human factors engineering) Lifecycle management and post-market surveillance exposure
Senior Expert in Drug–Device Combination Product Development , with a strong focus on
autoinjector platforms . This is a strategic and hands-on role within a transversal device team, supporting the development, industrialization, and documentation of patient-centric combination products across multiple programs.
Key Responsibilities Lead the
risk management workstream
for an autoinjector combination product platform from concept through commercialization Ensure compliance with global standards and regulations including
ISO 13485, ISO 14971, ICH Q9/Q8/Q10/Q12, 21 CFR Part 4, EU MDR Article 117 Partner closely with cross-functional stakeholders to align with design control and quality system expectations Support evaluation and selection of
documentation and development software tools Provide expert input on
component selection, human factors, V&V, and device reliability Prepare, review, and approve key device documentation (DHF, RMF, usability files, regulatory submissions) Contribute to continuous improvement of combination product development processes
Required Experience & Skills 15+ years
in drug–device combination product development (autoinjector experience strongly preferred) Proven expertise in
design control, risk management, DHF/RMF, technical and regulatory documentation Strong knowledge of relevant international standards and regulatory frameworks Fluent English required;
French is a strong advantage Comfortable working in a global matrix environment with external partners Strong analytical mindset, communication, and cross-functional influence
Nice to Have Experience with injection systems (pen injectors, safety syringes, on-body delivery) Familiarity with documentation/data integrity tools Knowledge of
IEC 62366
(human factors engineering) Lifecycle management and post-market surveillance exposure
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