Senior Associate, Regulatory Affairs - Human Factors - Remote

Overview

MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). This role involves supporting regulatory and human factors engineering initiatives across a diverse portfolio of medical device and life sciences clients.

In Short

• Draft usability engineering files and conduct risk analysis.
• Design usability studies and draft protocols.
• Support regulatory submissions including 510(k), IDE, PMA, and others.
• Communicate with regulatory bodies and clients.
• Collaborate with various MCRA departments.
• Lead projects with support from senior staff.
• Conduct post-market surveillance data analysis.
• Possess strong research and analytical skills.
• Handle multiple tasks and meet deadlines.
• Utilize MS Office and other technical skills.

Requirements

• Bachelor’s degree or higher in scientific, engineering, or regulatory discipline.
• Experience with medical device development is required.
• Experience with usability engineering is preferred.
• Strong problem-solving skills.
• Attention to detail and organizational skills.
• Effective interpersonal skills.
• Knowledge of statistical analysis is advantageous.

Benefits

• Work with a dynamic team in a leading advisory firm.
• Engage with a diverse portfolio of clients.
• Opportunities for professional development.
• Collaborate across multiple disciplines.
• Make a significant impact in the medical device industry.