Twist Bioscience
Regulatory Operations Specialist - Temporary
USA - Portland, OR · Contract
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About the role
- 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
- ●Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring
Responsibilities
- Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring
- Collaborate with cross-functional teams to obtain necessary product composition data and hazard
- Manage the review, approval, and distribution of SDS to internal and external stakeholders.
- 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.
- Expertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and
- Familiarity with Quality Management Systems and electronic document control systems (eQMS)
Requirements
- 2 years of experience Regulatory Operations within a biotechnology, life sciences, or
- Experience with Google Suite and/or MS Office Products required.
- influential, targeted to audience) required.
- competing demands is required
Nice to have
- 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
- compliance with global regulations.
- information for accurate SDS generation.
- Carries out duties in compliance with established business policies.
- Ability to travel 5%
- Follow regulatory and ISO 13485 requirements.
Compensation
- $31k-$42k
Benefits
- combination of education and work-related experience.
- Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and
This listing is sourced directly from Twist Bioscience's careers page and normalized into a canonical job model.