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About the Role

The Regulatory Operations Specialist ensures efficient and compliant management of regulatory documentation, focusing on Safety Data Sheets (SDS), product labeling, and SOPs to support global product compliance.

Responsibilities

• 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.
• Carry 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 needs.
• Perform other duties & projects as assigned.
• Ability to travel 5%.
• Follow regulatory and ISO 13485 requirements.

Requirements

• Minimally 2 years of experience in 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.

Skills

• Safety Data Sheets (SDS)
• Product labeling
• SOPs
• Google Suite
• MS Office Products
• Master Control
• Atlassian Confluence
• JIRA
• Written communication
• Oral communication

Location

• California
• San Francisco Bay Area

Work Type

• Full-time

Experience Level

• 2 years of experience

Education Level

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent combination of education and work-related experience.

Salary/Compensations

• $31—$42 USD

Benefits

• Bonus
• Equity
• Generous benefits package