Jobs / United States / Novartis Pharmaceuticals Corporation
Senior Expert Engineering RMCS
Novartis Pharmaceuticals Corporation · 🇺🇸 Schaftenau
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 75 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Novartis Pharmaceuticals Corporation paid sponsored hires in similar roles1 certified filing for “Expert Science & Technology” (Bioengineers and Biomedical Engineers) in NC: $113k–$113k, median $113k. Most were filed at wage level III (100%) — 3 lottery entries, ≈46% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Novartis Pharmaceuticals Corporation
The US Department of Labor certified 75 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Novartis Pharmaceuticals Corporation →
About the role
Salary Range: €66,918.00 - €117,800.00 Job Description Summary With 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. This 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. Job Description Location: Schaftenau, Austria Work Pattern: Hybrid Please note that this position does not include relocation support. Candidates should therefore already be based in, or able to work from, the advertised location. Key responsibilities: • Act as senior subject matter expert for device and combination product risk management in accordance with ISO 14971, MDR, FDA expectations, and Novartis internal standards. • Define, assess, and challenge technical/design, manufacturing, and use-related risks , ensuring risks are adequately mitigated and justified. • Develop and strengthen control strategies (e.g. testing vs. not testing, process controls, verification strategies) across development and lifecycle stages. • Drive consistency and quality of Risk Management Files (RMF), Risk Management Plans, and Risk Management Reports across projects and platforms. • Provide expert guidance to project teams on risk acceptability, residual risk justification, and benefit–risk considerations . • Support health authority submissions and interactions , including inspection readiness and responses related to risk management and control strategy. • Contribute to methodologies, templates, guidance documents, and training materials. • Coach and mentor junior experts and project team members, strengthening risk management capability and culture across the organization. • Proactively engage stakeholders to pre-align on risk positions and avoid late-stage surprises. Essential Requirements: • Advanced degree in engineering, life sciences, or a related technical discipline. • Fluent English – both spoken and written. • Extensive hands-on experience in medical device and/or drug–device combination product risk management . • Strong working knowledge of ISO 14971 , EU MDR, FDA device expectations, and Quality-by-Design principles. • Proven ability to translate complex technical risks into clear, defendable, and regulator-ready documentation . • Track record of influencing cross-functional stakeholders without direct authority. • Structured, analytical mindset with strong judgment and decision-making capability. Desirable: • Experience across multiple device platforms (e.g. autoinjectors, inhalers, pumps). • Exposure to combination products within pharmaceutical development. • Experience supporting regulatory submissions, audits, or inspections. • Ability to act as a reference point for best practices and emerging regulatory trends. • German language is not required but would be an advantage. Salary & Benefits: In 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