{"id":3324303,"url":"https://alion.io/job/roche-regulatory-specialist-diagnostics","title":"Regulatory Specialist Diagnostics","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":86,"open_postings":244,"ghost_share":0.045,"stale_share":0.561,"repost_share":0.123,"time_to_fill_p50_days":20,"computed_at":"2026-11-08T05:47:12Z"}},"role":"MedTech","role_family":"MedTech","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San José, Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":33000,"max_usd":83000,"period":"year","method":null,"sample_n":215},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"IVDR","optional":false}],"status":"closed","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-11-06T22:01:46Z","board_verified":false,"closed_at":"2026-11-06T22:01:46Z","days_open":11,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":11},"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\nRelocation benefits are not available for this job posting.\nAbout this position: Owns products from a RA perspective for the assigned area of responsibility. Shall obtain Regulatory approvals in defined markets in close cooperation with other functions. The documents/deliverables for submissions are coordinated and compiled in a timely manner to support planned product registration timelines, and basic registration strategies are developed and communicated with Health Authorities and stakeholders. The obtained Regulatory approvals/ permits/licenses products are maintained throughout the life cycle of the product by applying successful Regulatory change controls. The efficiency and the success of the Regulatory activities and strategies are maintained by clear agreements with other functions, stakeholders, and external partners (authorities, companies, NBs, etc.). The regulatory requirements and strategic aspects are understood, communicated and implemented, kept up to date and are transparent within the organization. The activities are driven by a mindset of innovation, agility, and the principles of VACC leadership.\nThe Opportunity:\nOversee regulatory document and submission compilation by developing registration dossiers for moderately complex products/programs and managing comprehensive global regulatory submissions and registration plans.\nManage external interfaces and regulatory strategy by partnering with stakeholders to understand problems/opportunities, providing effective solutions, developing influential external relationships, contributing to audit preparation/execution/follow-up, and applying regulatory framework knowledge (e.g., IVDR) to create strategies for legally marketing Roche products/programs of simple-to-moderate regulatory complexity.\nBuild strong stakeholder relationships and influence effectively by understanding organizational relationships, roles, needs and responsibilities, applying appropriate stakeholder management, communicating timely and clearly, and maintaining effective, enduring partnerships.\nDemonstrate sound decision-making and problem-solving with minimal supervision: complete daily activities accurately, present issues and solutions, gather relevant information, think through problems logically, identify options, make timely decisions, solve daily challenges, find agreeable stakeholder solutions, and escalate issues when needed.\nDrive innovation, agility and VAAC leadership by generating new ideas, leveraging diverse perspectives, seeking new opportunities and approaches, living the “we all lead” mindset, acting with integrity/courage/passion, honoring commitments, supporting inclusion and diversity, embracing change, new technologies, data literacy, regulatory tools and continuous productivity improvements.\nContribute strong teamwork and communication by building collaborative relationships, sharing information/knowledge/guidance, participating in conflict resolution, listening actively, expressing ideas clearly, being truthful, remaining open to others’ input, and recognizing colleagues’ contributions.\nWho you are:\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.","description_format":"text","description_chars":4213,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Prescription Drugs","Diagnostic Tests & IVD","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T09:17:02Z"},{"event":"close","at":"2026-11-06T22:01:46Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/roche-regulatory-specialist-diagnostics","json_url":"https://alion.io/job/roche-regulatory-specialist-diagnostics.json","meta":{"generated_at":"2026-11-09T00:30:51Z","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":1072,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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-specialist-diagnostics"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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-specialist-diagnostics"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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-specialist-diagnostics"},{"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-specialist-diagnostics\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-regulatory-specialist-diagnostics"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3324303}},{"tool":"search_jobs","arguments":{"company":"roche.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3324303},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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