{"id":2307571,"url":"https://alion.io/job/novartis-senior-expert-engineering-rmcs","title":"Senior Expert Engineering RMCS","company":{"id":5824,"name":"Novartis","domain":"novartis.com","url":"https://alion.io/company/novartis","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":86,"open_postings":63,"ghost_share":0,"stale_share":0.556,"repost_share":0.032,"time_to_fill_p50_days":35,"computed_at":"2026-10-15T05:46:00Z"}},"role":"Finance","role_family":"Finance","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Schaftenau, Austria"],"countries":["AT"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":66918,"max":117800,"currency":"EUR","period":"year","gross":null,"usd_annual":132016},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-11T23:46:04Z","employer_posted_date":"2026-10-11","last_verified_at":"2026-10-15T21:32:01Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Salary Range:\n€66,918.00 - €117,800.00Job Description Summary\nWith the increasing diversity and complexity of Novartis’ drug delivery device and drug-device combination product portfolio, robust and harmonized risk management and control strategies are critical to ensure patient safety, regulatory compliance, and sustainable product quality.As Senior Expert Risk Management & Control Strategy, you will act as a technical and strategic authority within the RMCS team, shaping how risks are identified, assessed, controlled, and documented across the device development lifecycle. You will work at the interface of design, quality, regulatory, manufacturing, and suppliers, enabling defendable decisions and fit-for-purpose control strategies for global development programs.\nThis is a high-impact individual contributor role, ideal for an expert who enjoys solving complex problems, influencing without authority, and raising the overall maturity of risk management practices across a portfolio.\nJob Description\nLocation: Schaftenau, Austria\nWork Pattern: Hybrid\nPlease note that this position does not include relocation support. Candidates should therefore already be based in, or able to work from, the advertised location.\nKey responsibilities:\nAct as senior subject matter expert for device and combination product risk management in accordance with ISO 14971, MDR, FDA expectations, and Novartis internal standards.\nDefine, assess, and challenge technical/design, manufacturing, and use-related risks, ensuring risks are adequately mitigated and justified.\nDevelop and strengthen control strategies (e.g. testing vs. not testing, process controls, verification strategies) across development and lifecycle stages.\nDrive consistency and quality of Risk Management Files (RMF), Risk Management Plans, and Risk Management Reports across projects and platforms.\nProvide expert guidance to project teams on risk acceptability, residual risk justification, and benefit-risk considerations.\nSupport health authority submissions and interactions, including inspection readiness and responses related to risk management and control strategy.\nContribute to methodologies, templates, guidance documents, and training materials.\nCoach and mentor junior experts and project team members, strengthening risk management capability and culture across the organization.\nProactively engage stakeholders to pre-align on risk positions and avoid late-stage surprises.\nEssential Requirements:\nAdvanced degree in engineering, life sciences, or a related technical discipline.\nFluent English - both spoken and written.\nExtensive hands-on experience in medical device and/or drug-device combination product risk management.\nStrong working knowledge of ISO 14971, EU MDR, FDA device expectations, and Quality-by-Design principles.\nProven ability to translate complex technical risks into clear, defendable, and regulator-ready documentation.\nTrack record of influencing cross-functional stakeholders without direct authority.\nStructured, analytical mindset with strong judgment and decision-making capability.\nDesirable:\nExperience across multiple device platforms (e.g. autoinjectors, inhalers, pumps).\nExposure to combination products within pharmaceutical development.\nExperience supporting regulatory submissions, audits, or inspections.\nAbility to act as a reference point for best practices and emerging regulatory trends.\nGerman language is not required but would be an advantage.\nSalary & Benefits:\nIn addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group.\nIn accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €65,504/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.\nAccessibility and accommodation:\nIf because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to  and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.\nSkills Desired\nData Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model","description_format":"text","description_chars":4937,"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":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Austria","iso":"AT","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-11T23:46:04Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":35,"reasons":["conf:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-15T05:46:00Z"},"pay":{"stated_usd_annual":132016,"is_top_pay":true},"html_url":"https://alion.io/job/novartis-senior-expert-engineering-rmcs","json_url":"https://alion.io/job/novartis-senior-expert-engineering-rmcs.json","meta":{"generated_at":"2026-10-15T21:51:06Z","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":33167,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-16T00:00:00Z"}},"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":5824},"rest":"https://alion.io/mcp/rest/get_company?id=5824"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnovartis-senior-expert-engineering-rmcs"},{"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%2Fnovartis-senior-expert-engineering-rmcs"},{"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%2Fnovartis-senior-expert-engineering-rmcs"},{"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/novartis-senior-expert-engineering-rmcs\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnovartis-senior-expert-engineering-rmcs"}]}