Medical Device Design & Development Engineer (Regulatory)

BioTalent; Turnhout; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

BioTalent is partnering with SciPharm to recruit a Design & Development Engineer for the Implantable Infusion Pump program in Turnhout, Belgium. You will participate in design, documentation, and regulatory activities to ensure product quality throughout the lifecycle.

You will review external documents, prepare DHF/TD/MDF content, support ISO 13485, MDR compliance, and collaborate with QA/RA and Manufacturing. Proficiency in English required; Dutch a plus.

Qualifications

• Bachelor's or Master's degree in Engineering or Technical Sciences.
• 2-3 years in technical documentation, quality, or regulatory roles in medical devices.
• Knowledge of DHF/TD/MDF structures under FDA 21 CFR Part 820, MDR, ISO 13485.

Responsabilités

• Review external documents from third parties for DHF/TD/MDF incorporation.
• Evaluate regulatory validity against FDA MDR and ISO 13485 requirements.
• Identify gaps and ask targeted questions to improve documents.
• Coordinate conversion of external docs to internal templates and control standards.
• Produce technical documentation for activities not outsourced.
• Maintain DHF/TD/MDF with traceability and version control.
• Support ISO 14971 risk management with QA/RA collaboration.
• Assist clinical investigations documentation with the clinical team.
• Collaborate with QA/RA and Manufacturing; support audits and CAPAs.
• Communicate with stakeholders in English; Dutch is a plus.

Connaissances

Regulatory compliance

Documentation review

Cross-functional collaboration

Attention to detail

English communication

Process improvement

Formation

Bachelor's or Master's degree in Engineering or Technical Sciences

Outils

MS Office

eQMS

Description du poste

BioTalent is partnering with SciPharm to recruit a Design & Development Engineer for the Implantable Infusion Pump program in Turnhout, Belgium. You will participate in design, documentation, and regulatory activities to ensure product quality throughout the lifecycle.

You will review external documents, prepare DHF/TD/MDF content, support ISO 13485, MDR compliance, and collaborate with QA/RA and Manufacturing. Proficiency in English required; Dutch a plus.