{"id":3825303,"url":"https://alion.io/job/abbott-regulatory-affairs-manager-2","title":"Regulatory Affairs Manager","company":{"id":2710,"name":"Abbott","domain":"abbott.com","url":"https://alion.io/company/abbott","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":338,"ghost_share":0.003,"stale_share":0.74,"repost_share":0.024,"time_to_fill_p50_days":28,"computed_at":"2026-11-06T05:58:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Maidenhead, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-05T18:16:41Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-06T15:13:47Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"JOB DESCRIPTION:\nPrimary Objective of Position\nLeads Regulatory Affairs strategy and activities across assigned EU/EFTA, UK, Region East, and Region Türkiye markets, ensuring regulatory compliance, market access, lifecycle management, and effective management of regulatory risk.\nLeads assessment and implementation of evolving regulatory requirements, engaging with regulatory authorities and trade associations to determine compliance strategies and communicate business impact.\nProvides regulatory leadership and guidance to commercial and cross-functional teams to support compliant business activities, market access, and lifecycle management.\nActs as Regulatory Affairs lead and designated backup across assigned regional markets, ensuring continuity of regulatory support and compliance oversight.\nDevelops and executes regulatory strategies for registrations, promotional review, performance studies, customer and tender support, and regulatory governance activities, including DOA requirements.\nProvides leadership and direction to regulatory colleagues across assigned markets, driving collaboration, capability development, accountability, and consistent execution of regulatory activities.\nMajor Accountabilities\nEnsures that all activities are performed in compliance with quality system requirements.\nReviews regulations from the assigned area countries and elevates according to CDx specific elevation process; assesses for impact and initiates and supports implementation action plans as needed; provides input into draft regulations to trade associations or competent authorities\nResponsible for following of the implementation of regulatory compliance as required by international & local regulations and Abbott policies and procedures.\nPerforms product notifications/registrations in the assigned countries, following country-specific requirements, processes and timelines\nActs as a primary contact for country regulatory Authorities\nCooperates with key trade Associations\nSupervises process for responding to customer and tender requests; provides responses to requests as needed\nActs as an SME for EMEA Promotional material review process\nPerforms approval of labelling and Ad Promo material in own native language\nResponsible for obtaining and maintenance of regulatory approval of all Core Diagnostics and Molecular Diagnostics products intended for distribution in Region East assigned countries.\nExecutes tasks required for regulatory compliance in areas of product notification/ registration, responding to customer and tender requests, promotional material approval in the assigned countries, performance evaluation and DOA distribution\nEnsures DOA distribution requirements are met in assigned countries\nEnsures performance study requirements are met guidance, notifications, submissions, follow-up with authorities and ethic committees.\nSupporting communication among divisions, dealers and health authorities to be able to get product approvals without any damage to given timelines\nEnsures that knowledge and experience acquired during their professional life is transferred to other team members\nPerform /act as backup for Registration / notification process in the assigned countries\nPerform above mentioned activities for Abbott divisions specified in service agreements\nRepresents RA in audits.\nEducation and Background\nScientific background (Degree in Medicine, Biology, Chemistry or Similar\nProven experience in IVD or similar industry\nSignificant experience working in an international work environment or on international projects \nProject management and negotiation skills\nFluent in English (written and spoken)\nStrong communication skills\nAbility to work independently, with attention to detail\nKnowledge of PC- and internet-based applications\nLeadership Skills\nThe base pay for this position is\nN/AIn specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nRegulatory OperationsDIVISION:\nCRLB Core LabLOCATION:\nUnited Kingdom > Maidenhead : Abbott HouseADDITIONAL LOCATIONS:\nWORK SHIFT:\nStandardTRAVEL:\nNoMEDICAL SURVEILLANCE:\nNot ApplicableSIGNIFICANT WORK ACTIVITIES:\nNot Applicable","description_format":"text","description_chars":4148,"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":[{"name":"United Kingdom","iso":"GB","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiovascular Devices","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-11-05T18:16:41Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Skilled Worker, Graduate Trainee, Senior or Specialist Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Skilled Worker; 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