Clinical Affairs Director

Clinical Affairs Lead

Skills Alliance  European Union (Remote)

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Clinical Affairs Lead EU – Orthopedics

📍 European Union | Full-time | Remote

Are you ready to take on a pivotal leadership role at the crossroads of clinical research, regulatory strategy, and groundbreaking product development? This is your chance to drive global clinical strategies, spearhead clinical evidence generation, and play a vital role in securing regulatory approvals for innovative medical device technologies.

The Opportunity

As the Director of Clinical Affairs, you’ll hold a high-impact leadership position overseeing clinical research activities across the complete product lifecycle. Collaborating with multidisciplinary teams—including Regulatory, R&D, Quality, and Commercial—you’ll also engage with investigators, CROs, and thought leaders to ensure the seamless execution of clinical programs.

Your Key Responsibilities

• Design and implement global clinical strategies that align with regulatory and product development goals.
• Lead clinical investigations in compliance with GCP, ISO 14155, EU MDR, and other regulatory standards.
• Generate compelling clinical evidence to demonstrate product safety, performance, and efficacy.
• Oversee planning, execution, and reporting for multiple clinical projects with precision and efficiency.
• Mentor and inspire the Clinical Affairs team to achieve excellence.
• Ensure strict adherence to study protocols, ethical standards, and regulatory expectations.
• Prepare and maintain essential clinical documentation, including CIPs, monitoring plans, eCRFs, and study reports.
• Foster strong relationships with investigators, hospitals, and CRO partners.
• Collaborate with RA/QA teams to support regulatory submissions and manage product lifecycle activities.
• Build and nurture networks with Key Opinion Leaders (KOLs) and clinical partners.
• Contribute to usability studies, risk assessments, and post-market clinical initiatives.

What We’re Looking For

• A Master’s degree or higher in life sciences, medicine, biomedical engineering, or a related field.
• Proven expertise in Clinical Affairs within the medical device industry, with a preference for Orthopedics.
• In-depth knowledge of EU MDR, FDA requirements, and clinical investigation regulations.
• A successful track record managing clinical studies and external partnerships with CROs and investigators.
• Strong understanding of clinical evaluation, risk management, and regulatory documentation.
• Exceptional leadership, communication, and project management skills.
• The ability to manage multiple projects in a dynamic, cross-functional environment.
• Fluency in English; additional European languages are a plus.

⚠️ Please note: Candidates must be based in the European Union and be legally authorized to work in the EU.

This is more than just a job—it’s your chance to make a tangible impact in the world of medical innovation. If you’re ready to lead, inspire, and innovate, we’d love to hear from you!