Global Clinical Quality & Compliance Lead

Cochlear; Mechelen; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Homeworking

Global exposure

Résumé du poste

Cochlear is seeking a Clinical Quality and Compliance (CQC) Manager to strengthen quality, compliance and systems for global clinical research activities. You will partner with CSI, CLTD, CBAS and regional process owners to provide GCP and ISO 14155 expertise, support audits, maintain QMS controls and drive improvements that keep studies compliant and efficient.

The role requires a Bachelor's degree in a life sciences field, 5+ years in clinical trials in medical devices or pharma, and fluent

Qualifications

• Bachelor's degree in healthcare, life sciences or equivalent.
• Minimum 5 years' clinical trials experience in medical devices/pharma.
• Knowledge of GCP, ISO 14155 and data protection principles.
• Experience with quality management documentation (SOPs, metrics).
• Strong attention to detail, organization and communication skills.
• Comfortable working across teams and time zones, English fluent.

Responsabilités

• Support CQC quality management activities and QMS changes.
• Provide SME on GCP, ISO 14155 and regulatory requirements.
• Assist with adoption of new clinical research standards.
• Contribute to quality oversight, audits, and inspection readiness.
• Act as system administrator for Vault Clinical and related activities.
• Collaborate with regional stakeholders on privacy, outsourcing and contracts.

Connaissances

GCP knowledge

Quality management

Audits & inspections

SOPs & documentation

ISO 14155

Cross-functional collaboration

English fluency

Formation

Bachelor's degree in Health Sciences

Outils

Vault Clinical

Description du poste

Cochlear is seeking a Clinical Quality and Compliance (CQC) Manager to strengthen quality, compliance and systems for global clinical research activities. You will partner with CSI, CLTD, CBAS and regional process owners to provide GCP and ISO 14155 expertise, support audits, maintain QMS controls and drive improvements that keep studies compliant and efficient.

The role requires a Bachelor's degree in a life sciences field, 5+ years in clinical trials in medical devices or pharma, and fluent