{"id":3535034,"url":"https://alion.io/job/laborie-regulatory-affairs-manager","title":"Regulatory Affairs Manager","company":{"id":2295654,"name":"Laborie","domain":"laborie.com","url":"https://alion.io/company/laborie-com","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Jobvite","truth_index":{"grade":"A","score":88,"open_postings":7,"ghost_share":0.143,"stale_share":0,"repost_share":0.571,"time_to_fill_p50_days":14,"computed_at":"2026-11-01T06:10:25Z"}},"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":"structured","locations":["Amsterdam, Netherlands"],"countries":["NL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":69000,"max_usd":141000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"EU MDR","optional":false}],"status":"live","first_seen_at":"2026-10-30T17:18:54Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-02T04:13:23Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"We believe that great healthcare is an essential safeguard of human dignity.\nAt Laborie, we know the work we do matters - it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.\nWe support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values ofAspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.\nWho We’re Looking For:\nAs a key member of the Regulatoryteam, the Regulatory Affairs Managerwill\nAct as the primary regulatory lead for multiple product lines and geographic regions, independently managing complex regulatory projects while influencing cross-functional decision. The Regulatory Affairs Managersignificantly impacts Laborie's ability to maintain global market access, particularly in the EMEA and LATAM regions, and enhances the ability for Regulatory Affairs to execute regulatory strategy andachieve business growth objectives in international markets.\nAbout the Role:\nDevelop and execute international regulatory strategies supporting new product introductions, product changes, and lifecycle management activities.\nProvide regulatory guidance to cross-functional teams throughout product development and commercialization.\nAssess regulatory pathways, submission requirements, timelines, risks, and mitigation strategies for international markets.\nLead and support regulatory submissions, registrations, renewals, and market access activities across EMEA, LATAM, and other international regions.\nPrepare, compile, review, and submit regulatory dossiers and supporting documentation as required.\nManage interactions with regulatory authorities, notified bodies, authorized representatives, and international distributors.\nSupport compliance with the European Medical Device Regulation (EU MDR 2017/745).\nContribute to the development and maintenance of technical documentation and post-market regulatory activities.\nMonitor global regulatory developments and provide recommendations regarding emerging regulatory requirements.\nAssess the regulatory impact of design, manufacturing, labeling, software, supplier, and process changes for international markets.\nSupport regulatory assessments related to complaints, adverse events, recalls, corrective actions, and field safety activities.\nServe as a key regulatory contact for international distributors and regional commercial teams.\nParticipate in regulatory inspections, audits, and external assessments.\nLead complex regulatory projects and mentor less experienced regulatory professionals.\nMinimum Qualifications:\nBachelor's degree in Engineering, Life Sciences, Biomedical Sciences, Regulatory Affairs, or a related scientific discipline.\n7+ years of regulatory affairs experience within the medical device industry.\nExperience managing international product registrations and regulatory submissions.\nWorking knowledge of EU MDR (2017/745) requirements.\nExperience supporting Class II and/or Class III medical devices.\nExperience interacting with regulatory authorities and notified bodies.\nExperience working within a regulated quality management system environment.\nStrong project management, analytical, and problem-solving skills.\nExcellent written and verbal communication skills in English.\nAbility to manage multiple priorities and deadlines in a global environment.\nWillingness to travel internationally up to approximately 5-10%.\nWhy Laborie:\nOur Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.\nCompetitive salary\nPaid time off and paid volunteer time\nHealth insurance group discounts\nCompany car where applicable \nPension plan\nFlexible working model in an internationalteam","description_format":"text","description_chars":4206,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Flexible schedule","Health insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Consumer Electronics","Health Care","Surgical Instruments & Devices","Cardiovascular Devices"],"lifecycle":[{"event":"open","at":"2026-10-30T17:18:54Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":14,"reasons":["conf:2","velocity","win:early"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/laborie-regulatory-affairs-manager","json_url":"https://alion.io/job/laborie-regulatory-affairs-manager.json","meta":{"generated_at":"2026-11-02T05:49:36Z","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":8330,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":2295654},"rest":"https://alion.io/mcp/rest/get_company?id=2295654"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flaborie-regulatory-affairs-manager"},{"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%2Flaborie-regulatory-affairs-manager"},{"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%2Flaborie-regulatory-affairs-manager"},{"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/laborie-regulatory-affairs-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flaborie-regulatory-affairs-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3535034}},{"tool":"search_jobs","arguments":{"company":"laborie.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3535034},"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. Docs: https://alion.io/developers"}}