Global SDS & Regulatory Documentation Specialist

Twist Bioscience; Portland (OR); On-site; USD 70,000 - 100,000; Full time

Job summary

Twist Bioscience in Portland, OR is seeking a Regulatory Operations Specialist to manage Safety Data Sheets, labeling, and SOP documentation while ensuring global regulatory compliance. The role focuses on accurate data collection, documentation control, and timely updates across products.

You will collaborate with science, quality, and regulatory teams, maintain EQMS records, and implement robust document-control processes in a fast-paced environment with about 5% travel.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent experience.
• Experience with medical device regulations and ISO 13485 awareness.
• 2+ years in Regulatory Operations or related field.

Responsibilities

• Initiate, author, and maintain SDS for all Twist products.
• Collaborate with cross-functional teams to obtain product data and hazard information.
• Manage review, approval, and distribution of SDS to stakeholders.
• Perform day-to-day administrative tasks in an EQMS system.
• Develop and document configuration changes with the Business Process Owner.

Skills

SDS Documentation

Regulatory Compliance

Cross-functional Collaboration

ISO 13485 Knowledge

Communication Skills

Documentation Control

Education

Bachelor's in Science

Tools

eQMS (electronic QMS)

Master Control

Confluence

JIRA

Google Workspace

MS Office

Job description

Twist Bioscience in Portland, OR is seeking a Regulatory Operations Specialist to manage Safety Data Sheets, labeling, and SOP documentation while ensuring global regulatory compliance. The role focuses on accurate data collection, documentation control, and timely updates across products.

You will collaborate with science, quality, and regulatory teams, maintain EQMS records, and implement robust document-control processes in a fast-paced environment with about 5% travel.