{"id":3201542,"url":"https://alion.io/job/arjo-regulatory-affairs-specialist","title":"Regulatory Affairs Specialist","company":{"id":1961447,"name":"Arjo","domain":"arjo.com","url":"https://alion.io/company/arjo-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Poland"],"countries":["PL"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":42000,"max_usd":110000,"period":"year","method":null,"sample_n":1456},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-17T02:00:00Z","employer_posted_date":"2026-10-17","last_verified_at":"2026-10-29T03:38:19Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"Empowering careers at ARJO\nAt Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?\nThis could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.\nPosition: Regulatory Affairs Specialist\nLocation: Komorniki (near Poznań)\nJob Type: Full time\nCompany: ArjoHuntleigh Polska sp. z o.o.\nThe Role\nAn exciting opportunity for a Regulatory Affairs Specialist to join the Malmo global QRC Product Registrations team, based in based in Komorniki, near Poznan, Poland. The role will be responsible for conducting international product registrations for all Arjo and OEM product portfolios and also supporting wider QRC projects and activities . Focus of the role will be to plan and execute regulatory strategies for the timely registration and approval of our products and also to ensure compliance with global and local country regulations and requirements.\nKey duties include:\nPrepares regulatory submissions for new and amended product licence applications for Class I, Im, and IIa medical devices. \nCommunicate progress of registrations with internal stakeholders: Project Owners, Engineering, Technical Publications, SSUs, Commercial and Management as required.\nLiaise with international affiliates, SSUs, distributors and competent authorities to ensure timely licence approvals.\nRecords registration activities on internal tracking databases.\nPrepare briefing summaries and training on regulations, processes and guidelines within area of responsibility.\nAssist in projects within the Regulatory Affairs function.\nAct as an internal auditor to established processes and external standards and regulations\nEnsure and maintain up to date knowledge on international regulatory requirements within assigned scope, and effectively communicate requirements to project teams and management.\nKnowledge/Skills/Experience:\nBA or BS degree with a major in a scientific discipline\nRegulatory experience in the medical device industry or experience in Quality Assurance or similar desirable\nMust be able to synthesise technical and clinical information to write clear, understandable licence application documents in EnglishMust be able to render clear and accurate judgments and have decision making skills.\nAbility to work well in cross-functional teams\nExcellent written and verbal communication skills\nAbility to work independently in a well-structured and systematic manner\nPersonal Qualities:\nAttention to Detail: Regulatory affairs specialists must meticulously review documents and ensure compliance with regulationsCuriosity: Questioning interest around the regulatory industry, the whole product lifecycle and our QMS processes, is a valuable quality\nAnalytical Thinking: They need to analyse complex regulations and apply them to specific situations\nCommunication Skills: Effective communication with regulatory bodies and internal teams is crucial\nProblem-Solving: They must be adept at identifying issues and finding compliant solutions\nConscientiousness: Being thorough and diligent in their work is essential\nAdaptability: The regulatory landscape can change frequently, so being adaptable is important\nWorking well with cross-functional teams is often necessary to ensure compliance\nCommitment to Continuous Learning: Staying updated with the latest regulations and guidelines\nA career in Regulatory and Quality Compliance will give you plenty of professional challenges. You will become part of close-knit team supporting many important areas of the Arjo business.\nPlease be aware that by applying for this role you are giving Arjo permission to store your information.\n#LI_EZ1\nAbout Arjo\nAt Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.\nFor more information about Arjo visitwww.arjo.com","description_format":"text","description_chars":4457,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Continuous learning"],"hiring_locations":[{"name":"Poland","iso":"PL","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-24T08:25:31Z"}],"visa":[],"liveness":{"score":36,"band":"fade","label":"Fading","p_open":1,"p_active":0.649,"p_room":0.55,"age_days":13,"expected_fill_days":13,"reasons":["conf:26","win:tail"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/arjo-regulatory-affairs-specialist","json_url":"https://alion.io/job/arjo-regulatory-affairs-specialist.json","meta":{"generated_at":"2026-10-30T23:34:28Z","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":14985,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-31T00:00:00Z"}},"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":1961447},"rest":"https://alion.io/mcp/rest/get_company?id=1961447"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Farjo-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%2Farjo-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%2Farjo-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/arjo-regulatory-affairs-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Farjo-regulatory-affairs-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3201542}},{"tool":"search_jobs","arguments":{"company":"arjo.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3201542},"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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