{"id":1259701,"url":"https://alion.io/job/twist-bioscience-regulatory-operations-specialist-temporary","title":"Regulatory Operations Specialist - Temporary","company":{"id":1814479,"name":"Twist Bioscience","domain":"twistbioscience.com","url":"https://alion.io/company/twistbioscience","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":7,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":31,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Operations","role_family":"Operations","seniority":"junior","employment_type":"contractor","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Portland, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":46000,"max_usd":95000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2247},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Confluence","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-07-28T15:42:45Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-19T09:21:39Z","board_verified":true,"closed_at":null,"days_open":82,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":82},"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.\nWhat You’ll Be Doing\nInitiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring \ncompliance with global regulations.\nCollaborate with cross-functional teams to obtain necessary product composition data and hazard\ninformation for accurate SDS generation.\nManage the review, approval, and distribution of SDS to internal and external stakeholders.\nCarries out duties in compliance with established business policies.\nPerform day to day administration activities on EQMS as per approved procedures.\nWork closely and collaborate with the Business Process Owner and EQMS users to develop and \ndocument configuration changes to meet business need\nPerform other duties & projects as assigned.\nAbility to travel 5%\nFollow regulatory and ISO 13485 requirements.\nWhat You’ll Bring to the Team\nBachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Biochemistry) or equivalent \ncombination of education and work-related experience.\nWorking 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.\n2 years of experience Regulatory Operations within a biotechnology, life sciences, or \nchemical manufacturing company or another Regulated Industry.\nExpertise in developing technical documentation, including Safety Data Sheets (SDS), SOP, and \nwork instructions\nFamiliarity with Quality Management Systems and electronic document control systems (eQMS)\nExperience with Google Suite and/or MS Office Products required.\nExperience with Master Control, Atlassian Confluence and/or JIRA preferred.\nStrong written and oral communication skills (timely, clear, concise, accurate, conclusive, \ninfluential, targeted to audience) required.\nFlexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and \ncompeting demands is required","description_format":"text","description_chars":2328,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Genomics & Genetic Testing","Synthetic Biology"],"lifecycle":[{"event":"open","at":"2026-09-25T20:03:00Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 15 · green card filings: 5","filings_12m":15,"filings_prev_12m":20,"green_card_filings_12m":5,"median_offered_wage_usd":133750,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.313,"p_room":0.28,"age_days":82,"expected_fill_days":31,"reasons":["conf:0","velocity","win:tail","crowd:junior"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/twist-bioscience-regulatory-operations-specialist-temporary","json_url":"https://alion.io/job/twist-bioscience-regulatory-operations-specialist-temporary.json","meta":{"generated_at":"2026-10-19T13:01:21Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":9224,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1814479},"rest":"https://alion.io/mcp/rest/get_company?id=1814479"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftwist-bioscience-regulatory-operations-specialist-temporary"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ftwist-bioscience-regulatory-operations-specialist-temporary"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ftwist-bioscience-regulatory-operations-specialist-temporary"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/twist-bioscience-regulatory-operations-specialist-temporary\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftwist-bioscience-regulatory-operations-specialist-temporary"}]}