{"id":3152460,"url":"https://alion.io/job/ust-lead-i-business-analysis-2","title":"Lead I - Business Analysis","company":{"id":1774626,"name":"UST","domain":"ust.com","url":"https://alion.io/company/ust-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"RippleHire","truth_index":{"grade":"B","score":75,"open_postings":134,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Analytics","role_family":"Analytics","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bengaluru, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":13500,"max_usd":31000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":631},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"IVDR","optional":false}],"status":"live","first_seen_at":"2026-10-23T13:00:59Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-26T00:35:27Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Who we are:\nAt UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 30,000 employees in 30+ countries, we build for boundless impact-touching billions of lives in the process. Visit us at .\nSummary:\nUST is looking for an experienced Regulatory Affairs professional to drive complex global regulatory submissions for IVD and Medical Device portfolios. The role involves defining regulatory pathways, executing submissions across multiple geographies, coordinating with health authorities and Notified Bodies, mentoring junior team members, and partnering with cross-functional teams to support regulatory compliance and successful market access.\nThe Opportunity:\nRole: Regulatory Affairs - IVD & Medical Devices\nExperience: 3-8 years\nDomain: IVD / Medical Devices\nFocus: Global Regulatory Submissions & Compliance\nKey Responsibilities\nLead the development and execution of global regulatory strategies for product registrations, renewals, and change controls across major markets.\nPrepare, review, and submit regulatory dossiers in accordance with MDR, IVDR, and other regional regulatory frameworks across APAC, LATAM, EMEA, and other markets.\nManage the end-to-end regulatory submission lifecycle, including:\nGap analysis\nRemediation activities\nApplication tracking\nRegulatory query and response coordination\nPartner with R&D, Quality, and Manufacturing teams to provide regulatory input into design and development documentation.\nCoordinate directly with Notified Bodies and health authorities to address queries and facilitate timely regulatory approvals.\nMaintain regulatory documentation and databases to support global portfolio maintenance.Guide regional teams on regulatory requirements, submission formats, and timelines to ensure consistency in execution.Support labeling reviews, product change assessments, and post-market compliance activities.Identify opportunities to improve submission preparation and document management workflows.Mentor regulatory specialists through on-the-job training and review of regulatory deliverables.Maintain accurate, complete, and up-to-date regulatory documentation and records.Ensure appropriate documentation practices are followed in accordance with applicable regulatory standards.What you need:\nRequired Skills: IVDR, MDR, Compliance Management, Business Analysis\nQualification:\nLife Sciences, Regulatory Affairs, Biomedical Engineering, or related degree\nAdvanced degree preferred\nWhat we believe:\nWe’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone, to champion diversity and inclusion and to place people at the centre of everything we do.\nHumility:\nWe will listen, learn, be empathetic and help selflessly in our interactions with everyone.\nHumanity:\nThrough business, we will better the lives of those less fortunate than ourselves.\nIntegrity:\nWe honour our commitments and act with responsibility in all our relationships.\nEqual Employment Opportunity Statement\nUST is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.\nAll employment decisions shall be made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.\nUST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.\n\nTo support and promote the values of UST.\n\nComply with all Company policies and procedures\nDigital Transformation Solutions Company | UST\nUST helps the world’s best organizations succeed through digital transformation, crafting disruptive solutions and strategies bringing our clients’ vision to life.","description_format":"text","description_chars":4305,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Information Technology","IT Consulting & Digital Transformation","IT Outsourcing & Dedicated Teams"],"lifecycle":[{"event":"open","at":"2026-10-23T13:00:59Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":1,"expected_fill_days":29,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/ust-lead-i-business-analysis-2","json_url":"https://alion.io/job/ust-lead-i-business-analysis-2.json","meta":{"generated_at":"2026-10-26T02:02:45Z","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":2632,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":1774626},"rest":"https://alion.io/mcp/rest/get_company?id=1774626"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fust-lead-i-business-analysis-2"},{"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%2Fust-lead-i-business-analysis-2"},{"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%2Fust-lead-i-business-analysis-2"},{"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/ust-lead-i-business-analysis-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fust-lead-i-business-analysis-2"}]}