{"id":1748788,"url":"https://alion.io/job/natera-regulatory-affairs-advisor","title":"Regulatory Affairs Advisor","company":{"id":3078,"name":"Natera","domain":"natera.com","url":"https://alion.io/company/natera","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":23,"ghost_share":0.13,"stale_share":0.478,"repost_share":0.174,"time_to_fill_p50_days":46,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":null,"work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":146100,"max":182600,"currency":"USD","period":"year","gross":null,"usd_annual":182600},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-02T21:21:07Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-21T12:49:14Z","board_verified":true,"closed_at":null,"days_open":18,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":18},"description":"POSITION SUMMARY\nTitle: Regulatory Advisor - FDA Pharma & IVDR\nNatera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing. The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample. This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management.\nYou will represent the RA team to internal and external stakeholders through written and verbal communication. This role maintains product registrations, change assessments, post-market surveillance reports, and records of communication with regulatory authorities. You will support the overall effectiveness of the RA team through contributions to staff development, process improvements, and maintaining a deep understanding of current regulatory requirements in the evolving diagnostics landscape.\nPRIMARY RESPONSIBILITIES\nRepresent the regulatory function on designated cross-functional teams.\n\nConduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling in the context of submissions or registrations.\n\nBuild and execute bold, practical regulatory strategies for complex regulatory affairs programs, with a heavy emphasis on FDA Pharma, IVDR, and In Vitro Diagnostic (IVD) systems.\n\nAdvocate for the least burdensome approaches to product clearance and approval while strictly interpreting and adhering to regulatory requirements.\n\nCoordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical worldwide registrations.\n\nMentor regulatory associates and support their career advancement.\n\nDeliver training on regulatory topics across internal teams.\n\nLead cross-functional teams to address major regulatory changes, compliance with new registration requirements, or process improvements.\n\nContribute to setting individual and departmental annual goals aligned with business objectives.\n\nReview and ensure regulatory compliance of advertising, promotion, and labeling across a common product line.\n\nTake personal accountability for identifying gaps in processes and proactively build data-driven solutions to improve them.\n\nEvaluate product changes for global regulatory submission impact.\n\nMay lead small teams.\n\nOther duties as assigned.\n\nQUALIFICATIONS\nBachelor’s degree in a life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.\n\nRegulatory Affairs Certification (RAC) preferred.\n\nMinimum of 8+ years of direct applicable regulatory experience in medical devices, laboratory-developed tests (LDTs), or pharma.\n\nDirect experience with FDA Pharma and IVDR submissions is highly preferred.\n\nExperience in Organ Health or Women's Health diagnostics is ideal and strongly preferred.\n\nIn Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus.\n\nPMA experience preferred.\n\nKNOWLEDGE, SKILLS, AND ABILITIES\nWorking knowledge of U.S. and EU Medical Device/IVD/IVDR, FDA Pharma, and/or laboratory developed test regulatory requirements.\n\nProactive, self-directed, and highly engaged.\n\nEmphasis on talent development and team building.\n\nUse sound scientific judgment to solve problems and make decisions even when rigid policies do not exist.\n\nManage multiple projects with urgency, staying organized and focused on delivering results.\n\nDemonstrated ability to effectively formulate and drive change.\n\nExperienced in continuous improvement projects, project management, and product development processes.\n\nThrive in ambiguity by navigating rapid change and actively building structure and standard operating procedures where they are missing.\n\nExcellent written and verbal communication skills, including the ability to communicate across cultures, work effectively with technical and scientific personnel, and negotiate clearly with Regulators.\n\nComputer literacy (PC, Microsoft Word/Excel/PowerPoint).\n\nThe pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.\nRemote USA\n$146,100—$182,600 USD\nOUR OPPORTUNITY\nNatera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.\nThe Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.\nWHAT WE OFFER\nCompetitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!\nFor more information, visit www.natera.com.\nNatera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.\nAll qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.\nIf you are based in California, we encourage you to read this important information for California residents. \nLink: https://www.natera.com/notice-of-data-collection-california-residents/\nPlease be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.\nFor more information:\n- BBB announcement on job scams \n- FBI Cyber Crime resource page","description_format":"text","description_chars":7743,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Diagnostic Tests & IVD","Genomics & Genetic Testing","Precision Medicine"],"lifecycle":[{"event":"open","at":"2026-10-03T07:36:32Z"},{"event":"close","at":"2026-10-05T16:33:55Z"},{"event":"reopen","at":"2026-10-06T14:41:33Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 74 · green card filings: 31","filings_12m":74,"filings_prev_12m":77,"green_card_filings_12m":31,"median_offered_wage_usd":134690,"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":51,"band":"ok","label":"Likely open","p_open":1,"p_active":0.568,"p_room":0.9,"age_days":18,"expected_fill_days":46,"reasons":["conf:2","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":182600,"is_top_pay":true},"html_url":"https://alion.io/job/natera-regulatory-affairs-advisor","json_url":"https://alion.io/job/natera-regulatory-affairs-advisor.json","meta":{"generated_at":"2026-10-21T13:12:56Z","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":18762,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":3078},"rest":"https://alion.io/mcp/rest/get_company?id=3078"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnatera-regulatory-affairs-advisor"},{"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%2Fnatera-regulatory-affairs-advisor"},{"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%2Fnatera-regulatory-affairs-advisor"},{"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/natera-regulatory-affairs-advisor\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnatera-regulatory-affairs-advisor"}]}