{"id":2204296,"url":"https://alion.io/job/roche-regulatory-affairs-manager-ivd-instruments-and-software","title":"Regulatory Affairs Manager - IVD Instruments and Software","company":{"id":13531,"name":"Roche","domain":"roche.com","url":"https://alion.io/company/roche","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":184,"ghost_share":0,"stale_share":0.679,"repost_share":0.022,"time_to_fill_p50_days":19,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tucson, United States","Carlsbad, United States","Indianapolis, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":106100,"max":197000,"currency":"USD","period":"year","gross":null,"usd_annual":197000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-09T22:35:01Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-27T14:37:27Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.\nThe Position\nA healthier future. That’s what drives us at Roche. We advance science so more people can access the healthcare they need-today and for generations to come. We work toward a world where everyone has more time with the people they love. That purpose is what makes us Roche.\nAt Roche Global Regulatory Affairs, we help bring the world’s leading diagnostics to the people who need them. We’re looking for a colleague who wants to make a meaningful contribution to that mission.\nIn this role, you’ll support regulatory projects and strategic topics across Laboratory Instruments, consumables and Software, including integrated hardware and software instrument systems. Your focus will be our Pathology and Digital Pathology portfolio within the Pathology Customer Area. You’ll work in an open, collaborative environment, partnering with colleagues across functions and countries to help shape regulatory pathways and support patient access to innovative diagnostics.\nThe Opportunity\nYou oversee regulatory document and submission compilation, which includes the development of submission/product registration dossiers of more complex products/programs. You develop and manage parts of comprehensive global regulatory submissions and registration plans. Specifically, you bring knowledge of USFDA regulations including IVD Instrument and Software, Accessories and System Reagents\nYou interface with external management. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders. You build effective and enduring external relationships and apply effective stakeholder management practices. You contribute to audits by supporting preparation, execution and follow up.\nYou lead the organization to adapt to the evolving regulatory environment and requirements. You have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making. You have the ability to interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance. You proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.\nYou effectively partner with end influence stakeholders to understand and provide best solutions. You take initiative to address problems or opportunities and involve collaborators for best solutions. You develop relationships that significantly influence the current and future direction for Roche and our products. \nYou have courage to make decisions even outside of scope/comfort zone and proactively initiate activities independently. You embrace good decision making principles.\nYou model VAAC Leadership and agility. You identify opportunities to develop VACC competency. You act with integrity, courage, passion and honor commitments and contribute to an inclusive environment which supports all dimensions of diversity. \nYou are able to pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes. You address and resolve conflict by creating an atmosphere of openness and trust. You bring out the best in people and teams.\nWho you are\nYou have a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.\nYou have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.\nYou have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.\nYou have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.\nYou have demonstrated the ability to manage more complex work and/or at parts of global projects.\nPreferred\nYou have experience with medical laboratory instruments, accessories, consumables and software product launch strategies for USFDA, EU and other global geographies \nLocations\nYou are local to Tucson, Indianapolis, Branchburg, or Carlsbad. This is an hybrid position.\nRelocation assistance is not available for this position.\nThe expected salary range for this position based on the primary location of Arizona is $106,100 to $197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.\nBenefits\nWho we are\nA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.\nLet’s build a healthier future, together.\nRoche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.\nIf you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.","description_format":"text","description_chars":6583,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Relocation assistance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Diagnostic Tests & IVD","Artificial Intelligence","Biotechnology","Health Care"],"lifecycle":[{"event":"open","at":"2026-10-09T22:35:01Z"}],"visa":[],"liveness":{"score":39,"band":"fade","label":"Fading","p_open":0.9,"p_active":0.573,"p_room":0.75,"age_days":17,"expected_fill_days":19,"reasons":["conf:53","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":{"stated_usd_annual":197000,"is_top_pay":true},"html_url":"https://alion.io/job/roche-regulatory-affairs-manager-ivd-instruments-and-software","json_url":"https://alion.io/job/roche-regulatory-affairs-manager-ivd-instruments-and-software.json","meta":{"generated_at":"2026-10-27T19:52:14Z","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":10685,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":13531},"rest":"https://alion.io/mcp/rest/get_company?id=13531"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Froche-regulatory-affairs-manager-ivd-instruments-and-software"},{"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%2Froche-regulatory-affairs-manager-ivd-instruments-and-software"},{"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%2Froche-regulatory-affairs-manager-ivd-instruments-and-software"},{"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/roche-regulatory-affairs-manager-ivd-instruments-and-software\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-regulatory-affairs-manager-ivd-instruments-and-software"}]}