Global Medical Affairs Specialist – Clinical Insights & Risk

Kaztronix LLC; Radnor (Delaware County); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Kaztronix LLC is seeking a Medical Affairs Specialist to support clinical activities, regulatory obligations, and continence of safe patient care worldwide. This role bridges clinical practice and research, contributing to risk evaluation, documentation, and real-world clinical workflows.

The successful candidate will have advanced medical training (PharmD/MD/RN), 3–5+ years of clinical experience, and strong global regulatory experience, enabling effective cross-functional collaboration.

Qualifications

• PharmD, MD, or RN degree required.
• Minimum of 3 years clinical and/or hospital experience.
• Minimum 5+ years of relevant medical experience.
• Strong experience in global regulatory (drug or device or combination products) and GxP guidelines.
• Excellent project management skills and excellent written and verbal communication skills.
• Prior supervisory experience preferred and quality improvement or educational experience.

Responsibilities

• Act as the primary liaison between clinical experts and cross functional teams.
• Support the Medical Affairs team by providing detailed clinical insights and ensuring regulatory documentation address the practical needs of healthcare providers and patients.
• Assist in developing and executing Clinical Evaluation Strategies that integrate current clinical practices and methodologies.
• Contribute to the clinical literature search by providing insights into relevant clinical trends and findings.
• Collaborate with clinical teams to conduct formative and summative usability studies, supporting products needs for both clinicians and patients.
• Review and interpret usability study results from a clinical perspective, providing guidance on usability improvements.
• Participate in risk management activities, including dFMEA, uFMEA, pFMEA, URRA, and the development of risk management plans.
• Evaluate potential hazards and harms within clinical contexts to support robust risk mitigation strategies.
• Support the creation of clinical documentation to reflect up-to-date clinical practices and standards.
• Facilitate communication between the Medical Affairs team and other stakeholders, so that clinical insights are disseminated and integrated effectively across projects.
• Completes required administrative tasks within the specified timeframes.
• Performs related duties as assigned.

Skills

Clinical expertise

Regulatory knowledge

Project management

Written and verbal communication

Team collaboration

Education

PharmD, MD, or RN degree

Job description

Kaztronix LLC is seeking a Medical Affairs Specialist to support clinical activities, regulatory obligations, and continence of safe patient care worldwide. This role bridges clinical practice and research, contributing to risk evaluation, documentation, and real-world clinical workflows.

The successful candidate will have advanced medical training (PharmD/MD/RN), 3–5+ years of clinical experience, and strong global regulatory experience, enabling effective cross-functional collaboration.