- Location
- BE Mechelen, Belgium
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Manager
- Experience
- 5+ years
- Education
- Bachelor
- Source
- Workday
Description
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. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!
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.
