Capio cfr a/s job

 ...surpass their goals and reach an overall high level of performance (raising the bar) * Protect/breath the team- and company culture (cfr. the way we do things) * Leading by example by closing deals and managing your own sales cycles * Facilitate/support group... 

 ...life sciences, or similar fields is an advantage E xperience in working with international medical device standards like FDA 21 CFR 820 & EU MDR and ISO 13485 is a clear advantage Strong communication and stakeholder management skills The ability to balance technical... 

 ...Vil duvære en del af vores velfungerende og fagligt engagerede team? På Capio vægter vi arbejdsglæde og højt fagligt engagement. Det gør vi fordi, at arbejdsglæde og faglighed skaber de bedste betingelser for at VI kan bidrage til det gode patientforløb. Så har arbejdsglæde... 

 ...fag og ved, at høj kvalitet ikke kun handler om den behandling, vi giver patienterne – men også om den kultur, vi skaber sammen. Hos Capio arbejder vi ud fra én fælles kerneopgave: at skabe høj patientsikkerhed, stærk faglighed, den bedste patientoplevelse og en... 

Vil du gøre en forskel for børn og unge? Børn og unge fortjener rammer, hvor der er tid, faglighed og mod til at tage ansvar Som børne- og ungerådgiver i Familieafdelingen bliver du en del af et fagligt fællesskab, hvor vi har opnormeret og organiseret arbejdet for...

 ...across Ambu’s footprint and collaborate across time zones Nice to have MedTech/life sciences background (GxP, ISO 13485, 21 CFR Part 11, CSV) Exposure to PLM, QMS, Infor M3 or equivalent ERP, plus iPaaS/data platforms, and modern security frameworks... 

 ...the design of secure automation network topologies. · Strong working knowledge of regulatory frameworks, including GMP, GAMP 5, 21 CFR Part 11, and data-integrity expectations, ensuring automation deliverables meet stringent pharma/biotech compliance requirements.... 

 ...combined with demonstrable experience in medical device development - Strong knowledge of design control principles, including 21 CFR 820.30 and ISO 13485 - Experience with requirements management, traceability, and system architecture documentation - Proficiency... 

 ...in a regulated environment – with a minimum of 3 years in the IT area Expertise in regulatory requirements such as GAMP 5, GxP, 21 CFR Part 11 and EU Annex 11, combined with hands-on experience in deviations, risk management, CAPA, RCA and A3 Several years of... 

 ...extensive experience and a solid understanding of Good Manufacturing Practices (GMP) and applicable regulations such as ICH Q7A and 21 CFR Part 211. Proven experience writing, reviewing, and approving technical documentation, communicating extensively with internal and... 

 ...readiness Follow up on regulatory updates and ensuring assessment gaps and necessary actions to meet requirements (i.e., EU GMP, 21 CFR and ICH guideline) Lead a GEMBA culture for compliance check and verification of processes Drive Lean leadership and encourage...