{"id":1699892,"url":"https://alion.io/job/hologic-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":720267,"name":"Hologic","domain":"hologic.com","url":"https://alion.io/company/hologic","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":82,"open_postings":14,"ghost_share":0,"stale_share":0.714,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Zaventem, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":40000,"max":50000,"currency":"EUR","period":"year","gross":true,"usd_annual":56034},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Outlook","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-08-24T12:12:17Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-29T04:33:06Z","board_verified":true,"closed_at":null,"days_open":65,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":65},"description":"Regulatory Affairs Specialist, Southern Europe\nLocation: Madrid, Spain OR Zaventem, Belgium\nHologic is a leading developer, manufacturer, and supplier of diagnostic products, medical imaging systems, and surgical products, with a strong emphasis on serving the healthcare needs of women. Our mission is to improve and save lives through early detection of cervical and breast cancer, improved diagnosis, and less invasive treatments.\nWe are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs EMEA team, taking ownership of regulatory activities across Southern Europe.\nWhat To Expect:\nManage and maintain regulatory notifications and registrations for medical devices across all Hologic product lines in Southern Europe including in Greece, Spain, Portugal, Italy, and Malta.\nServe as the primary contact with Competent Authorities in assigned countries, supporting communications as needed.\nReview scientific and clinical literature to support product registrations and ongoing regulatory compliance.\nReview and approve documentation, labelling, and promotional materials to ensure regulatory compliance.\nMaintain accurate regulatory records and databases, in-country registration requirements, and product documentation files.\nMonitor current and upcoming regulations, standards, and guidelines impacting the business, and communicate key updates to the RA team.\nSupport regulatory activities for new product launches and introductions, including participation in cross-functional core team meetings.\nRespond to regulatory inquiries from distributors, customers, sales, marketing, customer service, and other internal stakeholders.\nProvide regulatory support for tenders, ensuring complete and timely responses to meet business deadlines.\nRepresent the Regulatory Affairs function in internal and external meetings, including industry association meetings, and take ownership of follow-up actions.\nProvide broader regional regulatory support, maintain shared platforms such as network drives and SharePoint, and report progress regularly to the RA EMEA team.\nWhat We Expect:\n5+ years of professional experience in a Regulatory role within the life sciences industry, ideally within the medtech sector and product registration.\nFluent English and Spanish are essential. Italian and Portuguese are an asset.\nStrong analytical skills and a high level of attention to detail.\nStrong problem-solving skills, with the ability to propose pragmatic, compliant solutions.\nProficiency in IT tools such as Outlook, Word, Excel, and PowerPoint.\nSelf-motivated, proactive, curious, and eager to learn.\nWell-organised and able to work independently while collaborating effectively with cross-functional and international teams.\nStrong oral and written communication skills, including the ability to communicate complex regulatory concepts clearly to non-regulatory stakeholders.\nWillingness to travel occasionally (approximately 10%).\nSo Why Join Hologic?\nWe are committed to making Hologic a place where top talent comes to grow. To support your success, we provide:\nContinued development opportunities throughout your career, including exposure to regional and cross-functional initiatives.\nThe chance to directly impact women's health and patient outcomes across Southern Europe and beyond.\nIf you have the right skills, experience, and mindset and you are excited by the challenge of driving regulatory excellence across Southern Europe - apply today. We look forward to hearing from you.\nSalary: €40,000 - €50,000 gross per year\nThe final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances.","description_format":"text","description_chars":3729,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"Spanish","level":"Advanced (C1)","optional":false},{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Belgium","iso":"BE","kind":"country"},{"name":"Spain","iso":"ES","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Diagnostic Tests & IVD","Medical Imaging Systems","Women’s Health & Maternity"],"lifecycle":[{"event":"open","at":"2026-10-02T13:01:36Z"}],"visa":[],"liveness":{"score":19,"band":"cold","label":"Long shot","p_open":1,"p_active":0.525,"p_room":0.36,"age_days":65,"expected_fill_days":38,"reasons":["conf:1","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":56034,"is_top_pay":false},"html_url":"https://alion.io/job/hologic-regulatory-affairs-specialist","json_url":"https://alion.io/job/hologic-regulatory-affairs-specialist.json","meta":{"generated_at":"2026-10-29T11:28:03Z","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":17423,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":720267},"rest":"https://alion.io/mcp/rest/get_company?id=720267"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhologic-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%2Fhologic-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%2Fhologic-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/hologic-regulatory-affairs-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhologic-regulatory-affairs-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1699892}},{"tool":"search_jobs","arguments":{"company":"hologic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1699892},"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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