EMEA Director, Clinical Operations — Hearing Solutions

C01 Cochlear Limited (Australia); Göteborgs kommun; Hybrid; SEK 1,800,000 - 3,000,000; Full time

Job summary

Cochlear Limited seeks a Director of Clinical Operations – EMEA to design and drive the regional clinical ops strategy and deliver Cochlear-supported trials across Europe, Middle East and Africa. You will ensure high-quality research, regulatory compliance, and efficient operations.

You will lead cross-functional teams, manage budgets, and partner with Regulatory, Quality, and site investigators to advance Cochlear’s hearing solutions globally.

Qualifications

• Bachelor’s degree in a scientific or health-related discipline required.
• 8–10 years of progressive clinical operations experience with 3+ years in leadership.
• Experience managing regional clinical operations across multiple countries/regulatory jurisdictions.
• Deep knowledge of GCP, ISO14155, MDR/IVDR and regional requirements.
• People management and capability development experience.
• Strong budgeting, forecasting and resource optimization skills.
• Ability to translate strategy into operational execution and drive change.

Responsibilities

• Develop and implement the regional clinical operations strategy for EMEA.
• Lead delivery of Cochlear-sponsored clinical investigations across EMEA.
• Plan regional resources, allocate workload, and manage study start-up and enrolment.
• Oversee site performance, contracts, governance, and vendor relationships.
• Drive efficiency, standardise processes, and optimise vendor relationships.
• Manage regional budgets and ensure cost-effective use of resources.
• Build and develop high-performing teams and set clear performance expectations.
• Ensure compliance with QMS, GCP, ISO standards, MDR/IVDR, and local regs.
• Act as regional contact for regulatory inspections, audits, and ethics interactions.

Skills

Leadership

Multi-country operations

GCP & ISO14155 knowledge

Budget & financial management

Regulatory affairs collaboration

Data analytics

English fluency

Travel readiness

Education

Bachelor’s degree in scientific or health discipline

Master’s degree, MBA or Ph.D. (desirable)

Job description

Cochlear Limited seeks a Director of Clinical Operations – EMEA to design and drive the regional clinical ops strategy and deliver Cochlear-supported trials across Europe, Middle East and Africa. You will ensure high-quality research, regulatory compliance, and efficient operations.

You will lead cross-functional teams, manage budgets, and partner with Regulatory, Quality, and site investigators to advance Cochlear’s hearing solutions globally.