Regulatory Affairs Associate

BISCO, INC. is a company dedicated to quality and innovation in dental medical devices. They are seeking a Regulatory Affairs Associate to gain hands-on experience in product registration and compliance while supporting a collaborative Regulatory Affairs team.

Responsibilities

• Prepare and organize documentation for domestic and international regulatory submissions to support product approvals
• Maintain regulatory files and databases, and update information in internal systems to ensure accuracy and compliance
• Review documentation for regulatory compliance, including labeling and standard operating procedures
• Research regulatory requirements and assist with planning discussions to support submission strategies
• Collaborate with internal teams and external partners to facilitate smooth registration processes

Skills

• Bachelor's degree in a science field (e.g., Chemistry, Microbiology, Biology, Biochemistry or Engineering)
• 1+ years of regulatory affairs experience preferred
• Comfortable using Microsoft Office applications (Word and Excel) and common digital tools such as email and internet-based platforms
• Strong English writing and communication skills
• Exceptional attention to detail and accuracy in all tasks
• Organized and able to manage multiple priorities with confidence
• Curious and eager to learn, with a proactive approach to problem-solving
• Collaborative team player who adapts easily to changing priorities

Benefits

• Medical
• Dental
• And vision insurance
• HRA and FSA
• Short and long-term disability
• Life insurance
• PTO
• 401(k) profit-sharing with match
• And potential year-end bonuses

Company Overview