Clinical Quality and Compliance Manager

Change peoples 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 peoples lives.

We are looking for a Clinical Quality and Compliance (CQC) Manager to help strengthen the quality compliance and systems that enable Cochlears 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.

• 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

• Bachelors 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

• 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

Cochlears 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 peoples 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