{"id":1583084,"url":"https://alion.io/job/halma-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":51550,"name":"Halma","domain":"halma.com","url":"https://alion.io/company/halma","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":29,"ghost_share":0,"stale_share":0.897,"repost_share":0,"time_to_fill_p50_days":44,"computed_at":"2026-10-27T05:46:45Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Budapest, Hungary"],"countries":["HU"],"hiring_countries":["HU"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":21000,"max_usd":49000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":90},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-03T00:00:00Z","employer_posted_date":"2026-09-03","last_verified_at":"2026-10-27T04:23:17Z","board_verified":true,"closed_at":null,"days_open":54,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":54},"description":"Responsibilities\nProvides customer support on regulatory issues;\nLead CE marking activities (per MDD and EU MDR), including preparation and maintenance of product technical files and clinical evaluations;\nDevelops 510K submissions and obtains FDA approval;\nSupports product registrations for many countries on a worldwide basis;\nMonitor and analyze evolving global regulatory requirements and proactively recommend strategies to maintain compliance;\nSupport engineering teams in creating and/or updating risk management and FMEA documents for new and existing products;\nReview change requests/engineering changes and provides RA strategy\nSupport post-market surveillance activities, ensuring compliance with MDR and other regulatory requirements;\nParticipate in internal audits and support external regulatory inspections;\nProvide timely review and approval of product labeling and marketing claims for regulatory compliance;\nOther duties as assigned.\nRequirements\nA Bachelor's Degree required; Science focused preferred.\n4+ years Regulatory prior experience, medical device industry highly preferable.\nExtensive knowledge of medical device regulations and standards. (e.g. FDA 21 CFR 820, 803, 806, and 830, MDSAP, MDR, ISO 13485, etc.);\nProduct registration knowledge and experience on a worldwide basis;\nProficient with MS Office, including MS Word, Excel and PowerPoint.\nExcellent organizational and multi tasking skills;\nAbility to work under pressure with strict deadlines;\nDetail-oriented;\nExcellent oral and written communication skills in English;\nGood presentation skills\nNice-to-have\nKnowledge of standards IEC 60601-1, 60601-1-2, 62304, ISO 14971, 10993, 15223-1, 20417\nRoHS/REACH experience preferred\nFluent in Hungarian\nFurther languages\nWhat we offer\nHybrid/remote work model\n13th month pay\nConfigurable cafeteria package\nCompany laptop and cell phone\nCompany: #SunTech, #LI-AA4","description_format":"text","description_chars":1893,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Hungarian","level":"Advanced (C1)","optional":false},{"language":"English","level":"All levels","optional":false}]},"benefits":["Cafeteria"],"hiring_locations":[{"name":"Hungary","iso":"HU","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Telecommunications","Optical Communications","Laboratory Equipment"],"lifecycle":[{"event":"open","at":"2026-10-01T13:41:34Z"}],"visa":[],"liveness":{"score":24,"band":"cold","label":"Long shot","p_open":1,"p_active":0.555,"p_room":0.44,"age_days":54,"expected_fill_days":44,"reasons":["conf:1","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/halma-regulatory-affairs-specialist","json_url":"https://alion.io/job/halma-regulatory-affairs-specialist.json","meta":{"generated_at":"2026-10-27T21:58:12Z","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":13433,"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":51550},"rest":"https://alion.io/mcp/rest/get_company?id=51550"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhalma-regulatory-affairs-specialist"},{"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%2Fhalma-regulatory-affairs-specialist"},{"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%2Fhalma-regulatory-affairs-specialist"},{"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/halma-regulatory-affairs-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhalma-regulatory-affairs-specialist"}]}