Field Action Specialist - Bio-Rad Laboratories

Job Title: Field Action Specialist

Responsibilities:

• Coordinate and execute field action activities in compliance with FDA, MDSAP, ISO 13485, and other regulatory standards.
• Collaborate with product segments and global business units to ensure timely communication and resolution of field issues.
• Prepare and maintain documentation related to field actions, including reports and regulatory submissions.
• Conduct risk assessments and impact analyses for product recalls and corrections.
• Provide training and support to internal teams on field action processes and compliance requirements.

Qualifications:

• Bachelor's degree in a relevant field (Engineering, Life Sciences, etc.).
• 2+ years of experience in regulatory affairs or quality assurance in the medical device industry.
• Strong knowledge of FDA, ISO 13485, and MDSAP regulations.
• Excellent communication and project management skills.
• Detail-oriented with strong analytical abilities.