{"id":2271502,"url":"https://alion.io/job/ambu-global-process-lead-regulatory-affairs","title":"Global Process Lead Regulatory Affairs","company":{"id":2093467,"name":"Ambu","domain":"ambu.com","url":"https://alion.io/company/ambu-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Career sitemap","truth_index":{"grade":"A","score":100,"open_postings":3,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Biotech","role_family":"Biotech","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":["Ballerup, Denmark"],"countries":["DK"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":82000,"max_usd":225000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":85},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-10-11T07:28:29Z","employer_posted_date":"2026-10-11","last_verified_at":"2026-11-05T11:29:43Z","board_verified":false,"closed_at":"2026-11-05T11:29:43Z","days_open":25,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":25},"description":"Are you passionate about regulatory processes and ensuring they work effectively across the product lifecycle?\nDo you thrive in a structured, project-driven environment where your attention to detail and ability to create overview makes a real impact?\nIf you enjoy connecting the dots between processes, systems, documentation, and people, and occasionally asking \"does this actually make sense?\", you might fit right in.\nWe are looking for a Global Process Lead - Regulatory Affairs to join our Global Regulatory Affairs organization at our headquarters in Ballerup, Denmark.\nYou will become part of a collaborative and highly engaged team, working closely with stakeholders across functions and geographies. As Process Owner, you will help shape and develop regulatory processes across the product lifecycle and have real influence on how we work globally.\nYou will ensure that requirements, systems, documentation, and stakeholders work together in practice, not just on paper, while contributing to the implementation of a new Product Lifecycle Management system.\nYou will work across key Regulatory Affairs process areas, including labeling, product registration, and regulatory intelligence.\nKey responsibilities\nAct as Process Owner for the relevant regulatory process and ensure that it supports regulatory requirements while remaining aligned with related processes across the product lifecycle\nEnsure that the regulatory process remains effective, connected, and fit for purpose throughout the transition to a new lifecycle management system, while identifying opportunities for improvement \nContribute to the development and maintenance of relevant QMS documentation and ensure consistency between process requirements and operational ways of working\nIdentify dependencies, resolve gaps, and ensure alignment across functions and lifecycle stages\nWork closely with SMEs, Global Process Owners, and other stakeholders to align processes, responsibilities, interfaces, and supporting data requirements\nParticipate in internal and external audits as Process Owner and explain how the process is governed, implemented, and maintained\nSupport workshops, training, and change management activities to ensure consistent understanding and application of the process\nAbout you\nSkills and experience can be gained in many ways, and we know the perfect profile cannot be prescribed on paper. You are, however, likely to succeed in this role if you bring many of the following:\nA relevant academic degree in Life Sciences, Engineering, or similar, along with experience working within Regulatory Affairs in a regulated industry such as medical devices or pharma\nYou have a good understanding of regulatory processes and how they support products throughout the product lifecycle\nExperience with process ownership and process development in a regulated environment is a strong advantage\nAbility to shape and improve complex regulatory processes while ensuring alignment across functions and lifecycle stages\nA basic understanding of how systems support regulatory processes and data flows throughout the product lifecycle\nStrong stakeholder management skills and the ability to create alignment across functions and organizational levels\nA structured and pragmatic approach, combined with strong analytical and communication skills\nYou are fluent in English, both written and spoken\nAmbu - a visionary and international workplace where your efforts matter\nAmbu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.\nWe offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.\nWhen to apply\nAs an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.\nIf you have any questions about the position, you can contact Marianne Høy, Head of EndoIntelligence, Compliance and .","description_format":"text","description_chars":4587,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Medical Supplies & Consumables"],"lifecycle":[{"event":"open","at":"2026-10-11T07:28:29Z"},{"event":"close","at":"2026-11-05T11:29:43Z"}],"visa":[{"country":"DK","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"Certified for Denmark's Fast-track scheme","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Fast-track scheme","cap_exempt":false,"checked_at":"2026-11-09T07:32:21+00:00","sources":["SIRI: companies certified for the Fast-track scheme"],"filings_for_role_12m":0}],"liveness":null,"pay":null,"html_url":"https://alion.io/job/ambu-global-process-lead-regulatory-affairs","json_url":"https://alion.io/job/ambu-global-process-lead-regulatory-affairs.json","meta":{"generated_at":"2026-11-09T08:50:35Z","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":7663,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":2093467},"rest":"https://alion.io/mcp/rest/get_company?id=2093467"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fambu-global-process-lead-regulatory-affairs"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Fambu-global-process-lead-regulatory-affairs"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fambu-global-process-lead-regulatory-affairs"},{"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/ambu-global-process-lead-regulatory-affairs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fambu-global-process-lead-regulatory-affairs"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2271502}},{"tool":"search_jobs","arguments":{"company":"ambu.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2271502},"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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