{"id":2817158,"url":"https://alion.io/job/baxter-regulatory-affairs-qa-manager-ukie","title":"Regulatory Affairs & QA Manager UKIE","company":{"id":5835,"name":"Baxter","domain":"baxter.com","url":"https://alion.io/company/baxter","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":89,"open_postings":16,"ghost_share":0,"stale_share":0.625,"repost_share":0,"time_to_fill_p50_days":13,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Reading, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":61000,"max_usd":166000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":85},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-21T00:00:00Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-30T18:50:16Z","board_verified":true,"closed_at":null,"days_open":39,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":39},"description":"This is where your work makes a difference.\nAt Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.\nOur Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.\nHere, you will find more than just a job-you will find purpose and pride.\nRegulatory Affairs & QA Manager\nUK, Ireland & Malta\nWe are looking for an experienced Country Quality Assurance (CQA) & Regulatory Affairs (RA) Manager to lead our Quality and Regulatory function across the UK, Ireland and Malta.\nIn this pivotal leadership role, you will be responsible for shaping and executing regulatory strategies that support our product portfolio while ensuring a robust and compliant Quality Management System (QMS) across the region. You will provide strategic direction, operational oversight, and expert guidance on quality and regulatory matters, working closely with cross-functional and global teams to support business objectives and maintain compliance with applicable regulations.\nReporting as a key leader within the organisation, you will also manage and develop the UK, Ireland and Malta CQA & RA team, driving a culture of quality, compliance and continuous improvement.\nWhat You'll Be Doing\nRegulatory Affairs\nDevelop and execute regulatory strategies that support business goals, including new product launches and lifecycle management of marketed products.\nLead regulatory activities for designated product portfolios, including pharmaceuticals and medical devices.\nIdentify regulatory risks and implement effective mitigation plans.\nMonitor evolving regulatory requirements and ensure ongoing compliance with corporate policies and external regulations.\nPerform gap analyses of regulatory documentation and recommend practical solutions and improvements.\nTrack regulatory submissions, approvals and documentation through effective internal systems and processes.\nPrepare, review and approve product labelling, promotional materials and Standard Operating Procedures (SOPs) to ensure compliance with local regulations.\nBuild and maintain strong relationships with regulatory authorities.\nCollaborate closely with local marketing, commercial teams and global stakeholders to ensure regulatory deliverables align with business objectives.\nProvide expert regulatory guidance to cross-functional project teams.\nQuality Assurance\nLead the implementation, maintenance and continuous improvement of the local Quality Management System.\nEnsure compliance with Corporate Quality policies, EU GDP, EU GMP, ISO 9001, ISO 13485, MDR and other applicable local regulations.\nMonitor quality performance and regulatory compliance across distribution and commercialisation activities.\nSupport internal and external inspections and audits, including responses to observations and tracking corrective actions.\nDevelop and manage local self-inspection, training and customer eligibility programmes.\nCoordinate field actions, including recalls and safety notices.\nSupport complaint handling processes, including the review of customer communications and investigation activities.\nPartner with Pharmacovigilance, Warehouse & Distribution, Technical Services and Commercial teams to maintain strong quality oversight.\nLeadership & Stakeholder Management\nLead, coach and develop the UK, Ireland and Malta CQA & RA team.\nRepresent Quality and Regulatory Affairs within global, regional and cross-functional projects and initiatives.\nDrive collaboration across multiple functions in a matrix environment.\nAct as a trusted advisor to internal stakeholders on quality and regulatory matters.\nRepresent the organisation in industry groups and external forums where appropriate.\nWhat We're Looking For\nStrong scientific and technical knowledge within healthcare, pharmaceutical, medical device or related industries.\nProven experience in Regulatory Affairs, Quality Assurance or a related discipline.\nSolid understanding of drug and medical device regulations and Good Distribution Practices (GDP).\nDemonstrated ability to manage complex projects and competing priorities.\nStrong leadership, influencing and stakeholder management skills.\nExcellent communication, presentation and negotiation abilities.\nAbility to work effectively within a multinational and multicultural environment.\nA proactive, solution-focused mindset with strong attention to detail.\nQualifications\nEssential\nBachelor's degree (or equivalent) in Pharmacy, Life Sciences or a related scientific discipline.\nMinimum 5-7 years of experience in Regulatory Affairs, Quality Assurance or a related field.\nExperience leading people, projects or cross-functional teams.\nDesirable\nMaster's degree and/or PhD in a relevant scientific discipline.\nExperience within a healthcare, pharmaceutical, medical device or CRO environment.\nExperience managing both pharmaceutical and medical device portfolios.\nWhat are some of the benefits of working at Baxter?\nCompetitive total compensation package\nProfessional development opportunities\nHigh importance placed on work life balance\nEqual Employment Opportunity\nBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.\nReasonable Accommodations\nBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.\nRecruitment Fraud Notice\nBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.","description_format":"text","description_chars":6577,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Patient Monitoring","Hospital Equipment & Furniture","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-10-18T14:25:22Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Skilled Worker","cap_exempt":false,"checked_at":"2026-10-30T06:20:16+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.407,"p_room":0.35,"age_days":39,"expected_fill_days":13,"reasons":["conf:2","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-30T05:48:23Z"},"pay":null,"html_url":"https://alion.io/job/baxter-regulatory-affairs-qa-manager-ukie","json_url":"https://alion.io/job/baxter-regulatory-affairs-qa-manager-ukie.json","meta":{"generated_at":"2026-10-30T20:43:58Z","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":10869,"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":5835},"rest":"https://alion.io/mcp/rest/get_company?id=5835"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbaxter-regulatory-affairs-qa-manager-ukie"},{"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%2Fbaxter-regulatory-affairs-qa-manager-ukie"},{"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%2Fbaxter-regulatory-affairs-qa-manager-ukie"},{"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/baxter-regulatory-affairs-qa-manager-ukie\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbaxter-regulatory-affairs-qa-manager-ukie"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2817158}},{"tool":"search_jobs","arguments":{"company":"baxter.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2817158},"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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