{"id":1544324,"url":"https://alion.io/job/adaptive-biotech-regulatory-affairs-associate","title":"Regulatory Affairs Associate","company":{"id":668984,"name":"Adaptive Biotech","domain":"adaptivebiotech.com","url":"https://alion.io/company/adaptivebiotech","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":59000,"max_usd":110000,"period":"year","method":"global_role_seniority_cell","sample_n":92},"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":true,"technologies":[{"name":"PCR","optional":false}],"status":"live","first_seen_at":"2026-09-30T15:59:30Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-25T11:06:26Z","board_verified":true,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.\nAs an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlightthrough collaboration with bright, curious colleagues working at the apex of innovation and application.\nIt’s time for your next chapter. Discover your story with Adaptive.\nPosition Overview\nThe Regulatory Affairs Associate is responsible for assisting with assembling the regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and in international markets. This role also helps maintain FDA submission files and records, ex-US technical file documentation, and other documents and policies that support regulatory activities.\nKey Responsibilities and Essential Functions\nAssists in writing and implementing process improvements for Regulatory Affairs functions\nMaintains and performs regulatory document filing and retrieval in conjunction with SOPs\nCompiles, coordinates, and formats materials required in submissions, license applications, technical file documentation etc.\nMaintains files related to FDA/global regulatory registrations, including communications with FDA/Global regulatory agencies\nCoordinates and formats submissions per FDA and/or other global health authority requirements\nAssists in the creation and implementation of regulatory affairs department policies and procedures to ensure that regulatory compliance is maintained or enhanced\nSupport operations by reviewing incoming project contracts and provide guidance for regulatory requirements for projects, as required\nInforms the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product\nAll other duties as assigned\nPosition Requirements (Education, Experience, Other)\nRequired\nBachelor’s Degree\n2+ years of experience in regulatory affairs in the diagnostic or pharmaceutical industry, regulatory science or related degree or certification, or other related experience\nPreferred\nDemonstrates knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output. Knowledge of FDA and quality systems regulation (QSRs)\nPrior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories\nCompensation\nSalary Range: $38.56 - $57.88\nOther compensation elements to include:\nequity grant\nbonus eligible\nALERT:Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment. \nInterested in this position, but don’t meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!\nAdaptive is not currently sponsoring candidates requiring work authorization support for this position.\nAdaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.\nAdaptive's benefits at-a-glance.\nAdaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email .\nIf you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail . This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.\nNOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.","description_format":"text","description_chars":5721,"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":["Equity","Home office"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Molecular Diagnostics","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-30T21:57:51Z"}],"visa":[],"liveness":{"score":74,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.826,"p_room":0.9,"age_days":24,"expected_fill_days":57,"reasons":["conf:2","win:mid","comp:junior"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/adaptive-biotech-regulatory-affairs-associate","json_url":"https://alion.io/job/adaptive-biotech-regulatory-affairs-associate.json","meta":{"generated_at":"2026-10-25T14:00:37Z","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":19992,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":668984},"rest":"https://alion.io/mcp/rest/get_company?id=668984"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fadaptive-biotech-regulatory-affairs-associate"},{"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%2Fadaptive-biotech-regulatory-affairs-associate"},{"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%2Fadaptive-biotech-regulatory-affairs-associate"},{"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/adaptive-biotech-regulatory-affairs-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fadaptive-biotech-regulatory-affairs-associate"}]}