{"id":1215476,"url":"https://alion.io/job/abbott-laboratories-regulatory-affairs-manager-3","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":"A","score":87,"open_postings":440,"ghost_share":0.002,"stale_share":0.693,"repost_share":0.023,"time_to_fill_p50_days":14,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Biotech","role_family":"Biotech","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sydney, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":66000,"max_usd":158000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":136},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-09-25T08:12:17Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-29T15:45:11Z","board_verified":false,"closed_at":"2026-10-29T15:45:11Z","days_open":34,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":34},"description":"JOB DESCRIPTION:\nAbout Abbott\nAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Our Rapid Diagnostics division is about providing innovative ways to screen, diagnose and monitor a vast range of health conditions with greater speed, accuracy and efficiency. Abbott's rapid diagnostic tests allow healthcare professionals and their patients to get same-day results. For healthcare workers, this means they can diagnose and advise their patients in a single office visit. For patients, quicker results means earlier treatment, less anxiety, less time and money spent on repeat doctor visits and a faster return to good health.\nThe Role\nWe are seeking an experienced and motivated Regulatory Affairs Manager to lead regulatory compliance activities across our Australia, New Zealand, and Pacific Islands business. This is an exciting opportunity to play a critical role in bringing innovative healthcare solutions to market while ensuring compliance with applicable regulatory requirements.\nBased in Macquarie Park, NSW and reporting to the Director Regulatory Affairs APAC, you will act as the key regulatory expert and primary liaison with regulatory authorities, supporting a diverse portfolio across Infectious Disease, Cardiometabolic, Informatics, and Toxicology products.\nKey responsibilities\nManage product registrations and regulatory submissions with relevant authorities, ensuring compliance and timely approvals.\nMaintain existing product registrations and manage regulatory changes throughout the product lifecycle.\nLead post-market surveillance activities, including adverse event reporting, recalls, and field safety actions.\nReview and approve promotional and external communication materials to ensure regulatory compliance.\nManage biological and controlled substance import permits where required.\nMonitor and interpret regulatory developments impacting medical devices and related healthcare products.\nServe as the primary point of contact for regulatory agencies and external stakeholders.\nSupport clinical trials by reviewing protocols, assisting with ethics submissions, and coordinating sponsorship requirements.\nMaintain regulatory databases and tracking systems to support compliance and reporting activities.\nContribute to industry consultations and represent the organisation within relevant industry associations and working groups.\nProvide regulatory guidance, support, and training to internal stakeholders across the business.\nWhat we’re looking for:\nTo be successful in this role, you will have:\nEssential Qualifications & Experience\nBachelor of Science (BSc) or equivalent qualification.\nMinimum 3 years' experience in a Regulatory Affairs role within the medical device, diagnostics, healthcare, or related industry.\nDemonstrated experience working with the Australian Therapeutic Goods Administration (TGA) Medical Device Regulatory Framework.\nStrong understanding of regulatory requirements across Australia and New Zealand.\nKey Skills & Attributes\nStrong leadership and influencing capabilities.\nExcellent analytical and problem-solving skills.\nAbility to interpret and apply complex regulatory requirements.\nHigh level of attention to detail and commitment to quality.\nStrong project management and organisational skills.\nExcellent communication and stakeholder management abilities.\nAbility to work independently while managing multiple priorities.\nKnowledge of Quality Management Systems and regulatory compliance frameworks.\nHigh levels of integrity, professionalism, and confidentiality.\nWhy Abbott?\nAt Abbott, you'll be part of a purpose-driven organisation focused on helping people live healthier lives. You'll work with passionate and talented colleagues in a collaborative environment where innovation, continuous improvement, and professional growth are encouraged.\nWe also provide some fantastic benefits for our employees such as:\nDiscounted Healthcare\nAccess to Fitness Passport\nDiscounted Shares program\nLearning and development opportunities\nOnsite parking and a barista\nAnd Lots more…\nThe base pay for this position is\nN/AIn specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nRegulatoryDIVISION:\nID Infectious DiseaseLOCATION:\nAustralia > Macquarie Park : 299 Lane Cove RoadADDITIONAL LOCATIONS:\nWORK SHIFT:\nStandardTRAVEL:\nNot specifiedMEDICAL SURVEILLANCE:\nNot ApplicableSIGNIFICANT WORK ACTIVITIES:\nContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)","description_format":"text","description_chars":4611,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Australia","iso":"AU","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Cardiovascular Devices","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-09-25T08:12:17Z"},{"event":"close","at":"2026-10-29T15:45:11Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/abbott-laboratories-regulatory-affairs-manager-3","json_url":"https://alion.io/job/abbott-laboratories-regulatory-affairs-manager-3.json","meta":{"generated_at":"2026-10-29T18:04:35Z","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":26821,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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":2710},"rest":"https://alion.io/mcp/rest/get_company?id=2710"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabbott-laboratories-regulatory-affairs-manager-3"},{"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%2Fabbott-laboratories-regulatory-affairs-manager-3"},{"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%2Fabbott-laboratories-regulatory-affairs-manager-3"},{"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/abbott-laboratories-regulatory-affairs-manager-3\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbott-laboratories-regulatory-affairs-manager-3"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1215476}},{"tool":"search_jobs","arguments":{"company":"abbott.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1215476},"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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