Jobs / United States / Twist Bioscience Corporation
Regulatory Operations Specialist - Temporary
Twist Bioscience Corporation · 🇺🇸 USA - Portland, OR
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 11 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest May 2026) — the step every H-1B hire needs first. USCIS also records 9 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Twist Bioscience Corporation
The US Department of Labor certified 11 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest May 2026) — the step every H-1B hire needs first. USCIS also records 9 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Twist Bioscience Corporation →
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 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