Regulatory Operations Specialist - Temporary

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

The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP’s. This role is crucial in supporting global product compliance, ensuring that all documentation accurately reflects regulatory requirements and product specifications.

What You’ll Be Doing

• Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations.
• Collaborate with cross-functional teams to obtain necessary product composition data and hazard information for accurate SDS generation.
• Manage the review, approval, and distribution of SDS to internal and external stakeholders.
• Carries out duties in compliance with established business policies.
• Perform day to day administration activities on EQMS as per approved procedures.
• Work closely and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need.
• Perform other duties & projects as assigned.
• Ability to travel 5%
• Follow regulatory and ISO 13485 requirements.

What You’ll Bring to the Team

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent combination of education and work-related experience.
• Working knowledge of medical device regulations, including ISO 13485 and EU IVDR (In Vitro Diagnostic Regulation); experience supporting regulatory documentation in an IVD or medical device environment strongly preferred.
• 2 years of experience Regulatory Operations within a biotechnology, life sciences, or Chemical Manufacturing Company Or Another Regulated Industry.
• Expertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and work instructions.
• Familiarity with Quality Management Systems and electronic document control systems (eQMS).
• Experience with Google Suite and/or MS Office Products required.
• Experience with Master Control, Atlassian Confluence and/or JIRA preferred.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required.