Job Description

About the Role

We are seeking a Clinical Affairs Manager who combines operational precision with strategic awareness. This role is ideal for an experienced clinical professional ready to own key components of global clinical programs, collaborate across teams, and help shape the future of clinical innovation in a high-growth medical device environment. You will support and execute on strategies that deliver regulatory success, evidence generation, and improved patient outcomes.

Key Responsibilities

Strategic & Tactical Execution

• Support the development and execution of global clinical strategies aligned with company objectives.
• Partner with executive leadership to deliver clinical data that informs product development, market access, and regulatory pathways.
• Assist in integrating digital health technologies, AI, or robotics into clinical trials and post-market evidence strategies.

Clinical Study Operations

• Manage the design, implementation, and oversight of clinical trials (pre- and post-market), ensuring adherence to regulatory and ethical standards.
• Drive study start-up, site selection, patient recruitment, vendor management, and trial monitoring.
• Collaborate with CROs and study sites to ensure timely execution and high-quality data capture.

Regulatory & Compliance

• Ensure clinical programs are inspection-ready and aligned with FDA, EU MDR, and international requirements.
• Support the preparation of regulatory submissions and clinical evaluation reports (CERs).
• Act as a liaison with regulatory, quality, and R&D teams to ensure integrated clinical strategies.

Team Collaboration & Communication

• Provide day-to-day leadership to Clinical Affairs Associates or support team members, fostering a culture of accountability and innovation.
• Prepare presentations and reports for internal stakeholders and external partners.
• Maintain ongoing communication with key opinion leaders (KOLs), investigators, and external collaborators.

Qualifications

Must-Haves:

• 8+ years of experience in clinical research, with at least 2 years in a management or team leadership role.
• Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field (Master’s or advanced degree preferred).
• Proven experience managing clinical studies in medical devices (orthopedics experience is a plus).
• Strong working knowledge of GCP, ISO 14155, FDA, and EU MDR requirements.
• Excellent cross-functional communication and project management skills.

Preferred:

• Certification such as CCRA, CCRC, or RAC.
• Experience with emerging tech (AI, robotics, digital health) in clinical studies.
• Exposure to regulatory submissions and audit readiness.

Why Join Us

• Play a pivotal role in advancing clinical programs for cutting-edge technologies.
• Be part of a mission-driven company focused on innovation, purpose, and impact.
• Enjoy competitive compensation, stock options, and flexible work arrangements.
• Gain exposure to strategic decision-making in collaboration with senior leadership.

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