Director Clinical Operations EMEA

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

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 say the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

The Director of Clinical Operations – EMEA will develop and implement the regional clinical operations strategy and lead the delivery of Cochlear‑sponsored clinical investigations across EMEA. This role is accountable for ensuring high‑quality clinical research delivery, while maintaining regulatory excellence, operational efficiency, and financial accountability.

Key Accountabilities

• Develop and implement the Clinical Operations strategy for study execution across EMEA, ensuring studies are delivered on time, within budget, and to high quality standards
• Plan and allocate regional resources, ensuring workload is effectively distributed and aligned to business priorities
• Oversee study start‑up, site activation, enrolment progress and site performance, using metrics to identify and resolve issues proactively
• Manage investigator, site, CRO and vendor relationships, including contracting frameworks, performance governance, escalation and continuous improvement
• Drive operational efficiency initiatives, identifying opportunities to standardise processes, leverage technology, optimise vendor relationships and reduce waste
• Manage regional clinical investigation budgets and seek opportunities to improve the cost‑effective use of resources while maintaining study quality and compliance
• Build organisational capability by assessing talent, identifying capability gaps, supporting development plans and setting clear performance expectations
• Ensure regional clinical study processes comply with Cochlear’s Quality Management System, Good Clinical Practice, relevant ISO standards, MDR/IVDR and applicable national regulations
• Act as the regional point of contact for regulatory inspections, audits and ethics committee interactions, and ensure safety reporting compliance across applicable requirements

About You

• Bachelor’s degree in a scientific or health‑related discipline
• 8–10 years of progressive clinical operations experience within the pharmaceutical or medical device industries, including at least 3 years in leadership roles
• Proven experience managing clinical operations across multiple countries and regulatory jurisdictions
• Strong track record of planning and executing complex, multi‑site clinical investigations
• Deep knowledge of Good Clinical Practice, ISO14155, MDR/IVDR and applicable regional/country‑specific clinical research requirements
• Experienced in people management and development, with the ability to build and lead high‑performing teams
• Strong financial acumen, including budget development, financial management, forecasting and resource optimisation
• Demonstrated ability to translate organisational strategy into operational execution, navigate ambiguity and deliver change
• Collaborative and influential communicator, able to partner effectively with Regulatory Affairs, Quality, Commercial, sites, investigators, vendors and other external partners
• Strong analytical skills, with the ability to use data, metrics and dashboards to drive decision‑making and continuous improvement
• Cultural intelligence and the ability to work effectively across diverse organisational and cultural contexts
• Fluent in English, with willingness and ability to travel internationally approximately 20%

Desired Skills

• Master’s degree, MBA or Ph.D. in a scientific, health or business discipline
• Broad understanding of medical devices or instrumentation used in the hearing implant therapy area
• Experience across additional business areas such as Operations, Quality Assurance, Regulatory Affairs, Project Management or Commercial
• Understanding of emerging clinical operations trends, including decentralised trials, digital health technologies, patient‑centric research and risk‑based monitoring approaches
• Experience successfully building and developing regional clinical operations teams
• Established relationships with investigators, clinical research professionals and regulatory authorities across EMEA
• Additional language skills highly valued

Development Value of This Role

Lead clinical operations across a diverse geographic region with multiple regulatory jurisdictions, healthcare systems and cultural contexts. Serve as a critical bridge between Global Clinical Operations strategy and regional execution. Gain significant visibility with senior management, regional commercial teams and external Cochlear customers across EMEA. Represent Cochlear at regional and international forums and contribute to global clinical strategy and process development. Deepen expertise in regional healthcare systems, regulatory frameworks and market dynamics while making a meaningful impact on Cochlear’s ability to bring life‑changing hearing solutions to patients.