Clinical Quality and Compliance Manager

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

Change people's lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives.

The Opportunity We are looking for a Clinical Quality and Compliance (CQC) Manager to help strengthen the quality, compliance and systems that enable Cochlear's global clinical research activities. In this role, you will work with internal stakeholders within Clinical Strategy and Innovation (CSI), CLTD, CBAS, and regional process owners, internal clinical research sites, investigators, and vendors. You will provide GCP and EMEA-specific clinical regulatory expertise, support audits and related quality assurance activities, maintain strong QMS process and clinical system controls, and help drive practical improvements that keep our clinical research compliant, efficient and of high quality. This is an opportunity to combine clinical research quality expertise with hands‑on system, process and stakeholder work in a global, purpose-led organisation.

Key Accountabilities

• Support CQC quality management activities, including QMS change management, process feedback and updates to CQC-owned QMS processes
• Provide subject matter expertise on GCP, (ISO 14155), Good Documentation Practice and applicable local clinical investigation regulations
• Support process owners with the assessment and implementation of new or revised clinical research standards and regulations
• Contribute to clinical investigation quality oversight, including quality checks of essential documents and milestone checkpoints
• Contribute to clinical investigation quality assurance through risk and issue management, audit readiness and inspection support, remediation activities and compliance reporting
• Act as a Clinical Business and System Administrator for Vault Clinical, supporting users, UAT activities, training, data oversight and licence or budget-related activities
• Partner with internal regional stakeholders on clinical research compliance topics such as privacy, insurance, outsourcing and contracts
• Identify and contribute to continuous improvement initiatives across quality management, quality assurance and clinical systems

About You

• Bachelor's degree in Healthcare, Life Sciences, Nursing, Public Health or equivalent
• Minimum 5 years' clinical trials experience within the medical device, pharmaceutical or biotechnology industry
• Practical working knowledge of GCP, preferably ISO 14155, clinical research regulations, GDP and applicable data protection or privacy principles
• Experience contributing to quality management documentation such as SOPs issue management or metrics
• Strong attention to detail, with excellent organisational, time management and communication skills
• Comfortable working independently and collaboratively across teams, functions and time zones
• Fluent in English, with willingness to travel locally and internationally occasionally as required

What You Will Gain

• Global exposure across clinical quality, compliance and clinical systems with the world leader in implantable hearing solutions
• The chance to deepen your expertise in ISO 14155 GCP and clinical investigation regulations
• A varied role connecting quality, clinical research, systems, audit readiness and continuous improvement
• A meaningful opportunity to help deliver high-quality clinical research that supports life-changing hearing solutions for patients

What we offer

• An attractive remuneration package and flexible extra-legal benefits
• An extensive onboarding and training program
• An enjoyable work environment with attention to life-work balance and homeworking
• A stimulating environment with growth opportunities and opportunity to meet multi-disciplinary colleagues across the globe
• This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day.

Cochlear Summary

Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people's lives. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now. And Always.

Cochlear is the global market leader in implantable hearing solutions including cochlear implant systems (CI) and bone anchored hearing aids (Baha™).

Equal opportunities

Cochlear is committed to providing equal opportunities to avoid unlawful discrimination on the grounds of race, sex, disability, sexual orientation, religion/belief or age. In line with our corporate ethics and statutory obligations we strive to ensure that the work environment is free of harassment and bullying and that everyone is treated with dignity and respect - this is an important aspect of ensuring equal opportunities in employment.

Our growth is creating great opportunities! Our team is expanding and we want to hire the most talented people we can. Continued success depends on it. We're the global leader in implantable hearing solutions. We have provided more than 600,000 implantable devices, helping people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.