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Roche
Roche
H1B vīzas sponsorsFarmaceitiskie produktiVeselības apdrošināšanaVeselības aprūpe
Roche ir globāls veselības aprūpes un farmācijas uzņēmums, kas koncentrējas uz pacientu aprūpes uzlabošanu, izmantojot pētniecību un izstrādi, digitālās inovācijas un sadarbību. Uzņēmumā strādā vairāk nekā 101 000 darbinieku, un tas apvieno zināšanas tehnoloģiju, ražošanas, biznesa stratēģijas un citās jomās, kas atbalsta inovācijas veselības aprūpē. Roche savās starptautiskajās komandās uzsver daudzveidību, vienlīdzību un iekļaušanu, kā arī piedāvā karjeras iespējas pieredzējušiem profesionāļiem, studentiem un absolventiem, tostarp iespējas, kas saistītas ar uzņēmuma darbību Vācijā, Austrijā un Šveicē.
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Vakances uzņēmumā

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.

USAmerikas Savienotās ValstisAZArizonaNJŅūdžersija
106 100 $ – 197 000 $ / gads
HibrīdiPilna slodzeVidējais līmenisVecākais speciālistsNepieciešamā Valoda: angļuAtbilstība

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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.

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