LogoFresh Jobs Ahead
Roche
Roche
Sponzor vizuma H1BFarmacevtski izdelkiZdravstveno varstvoZdravstveno zavarovanje
Roche je globalno zdravstveno in farmacevtsko podjetje, ki se osredotoča na izboljšanje zdravstvene oskrbe pacientov z raziskavami in razvojem, digitalnimi inovacijami ter sodelovanjem. Z več kot 101.000 zaposlenimi združuje strokovno znanje s področij tehnologije, proizvodnje, poslovne strategije in drugih funkcij, ki podpirajo inovacije v zdravstvu. Roche poudarja raznolikost, enakost in vključenost v svojih mednarodnih ekipah ter ponuja karierne priložnosti za izkušene strokovnjake, študente in diplomante, vključno z možnostmi, povezanimi z njenim delovanjem v Nemčiji, Avstriji in Švici.
LinkedIn
Delovna mesta v podjetju

Roche Regulatory Affairs Manager, IVD Instruments and Software

Lead regulatory submissions and strategy for Roche Diagnostics’ IVD instruments and software. Support product approvals across global markets, with a focus on Pathology and Digital Pathology.

USZdružene države AmerikeAZArizonaNJNew Jersey
106.100 $ – 197.000 $ / leto
HibridnoPolni delovni časSrednja ravenSeniorZahtevani Jezik: angleščinaSkladnost

Opis

  • Coordinate regulatory projects for laboratory instruments, consumables, software, and integrated systems.
  • Support the Pathology and Digital Pathology portfolios within the Pathology Customer Area.
  • Oversee regulatory documents and submission dossiers for complex products and programs.
  • Develop and manage portions of global regulatory submissions and registration plans.
  • Apply US FDA requirements to IVD instruments, software, accessories, and system reagents.
  • Work with external leaders, customers, and other stakeholders.
  • Build external partnerships and apply stakeholder management practices.
  • Assist with audit preparation, execution, and follow-up.
  • Guide organizational adaptation to changing regulatory requirements.
  • Interpret regulator perspectives and apply regional regulatory strategies.
  • Develop strategies that address obstacles and support worldwide product approvals.
  • Collaborate with stakeholders to identify and deliver solutions.
  • Address challenges and opportunities with input from collaborators.
  • Build relationships that help shape Roche’s direction and its products.
  • Make independent decisions and proactively initiate work.
  • Demonstrate VAAC Leadership and agility while supporting an inclusive environment.
  • Unite colleagues around shared goals, resolve conflict, and improve team outcomes.

Zahteve

  • Bachelor’s or master’s degree in life sciences, data science, or a related field, or equivalent experience.
  • An advanced degree is preferred.
  • Experience in IVDs, medical devices, pharmaceuticals, or biopharmaceuticals with significant regulatory affairs experience: 3–5 years with a PhD, 5–7 years with a master’s degree, or 6–8 years with a bachelor’s degree, or equivalent.
  • Demonstrated experience with Daily Management and Continuous Improvement practices.
  • Knowledge of European, US, Chinese, and other international regulations.
  • Ability to interpret and implement quality standards is an advantage.
  • Ability to manage complex work and parts of global projects.
  • Experience with medical laboratory instruments, accessories, consumables, and software launch strategies in the US, EU, and other global markets is preferred.
  • Must live near Tucson, Indianapolis, Branchburg, or Carlsbad.
  • Relocation assistance is not available.

Ugodnosti

  • A discretionary annual bonus may be offered based on individual and company performance.
  • Benefits information is available at the provided link.
  • Roche is an equal opportunity employer.
  • Accommodation is available for applicants with disabilities during the online application process.

Sorodna delovna mesta

General Dynamics Information Technology

Senior AI Engineer and Architect

General Dynamics Information Technology
Sponzor vizuma H1BLogistikaSvetovanjeZdravstveno varstvo
USZdružene države Amerike
149.469 $ – 201.250 $ / leto
Na daljavoPolni delovni časSeniorVodjaZahtevani Jezik: angleščinaInženir strojnega učenjaInženir umetne inteligence
AWSAzureJavaOblakPorazdeljeni sistemiPythonRust

Lead AI, machine learning, and large language model architecture for General Dynamics Information Technology’s government, defense, and intelligence missions. Take solutions from proof of concept to production across complex operational settings.

Odpri