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Medical Devices RA Specialist
SKY Medical, a.s.
Place of work
Remote work
Remote work
Contract type
full-time, part-time, agreement-based (Temporary jobs), trade licence
full-time, part-time, agreement-based (Temporary jobs), trade licence
Start date
01.05.2021
01.05.2021
Wage (gross)
1 000 - 2 000 EUR/monthsalary solely based on experience in disposable sterile medical devices RA and type of cooperation (full time / part time)
1 000 - 2 000 EUR/monthsalary solely based on experience in disposable sterile medical devices RA and type of cooperation (full time / part time)
Information about the position
Job description, responsibilities and duties
Experience in Medical Device - MUST
Compile and control product technical files for MDR and 510k product registrations
Coordination of CER, PMS, PMCF, PSUR
Coordination of compliance with ISO 10993
Review compliance and update existing technical files
Review device labeling (Including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes.
Review and approve design and manufacturing changes for compliance with applicable regulations
Support quality system audits by notified bodies, government agencies and customers (if applicable)
Provide daily hands-on regulatory and quality internal support, RA service to clients
Comminication with Notified bodies
Change notification to Notified bodies
Coordination of activities with SUKL
Perform all other essential duties as assigned
Compile and control product technical files for MDR and 510k product registrations
Coordination of CER, PMS, PMCF, PSUR
Coordination of compliance with ISO 10993
Review compliance and update existing technical files
Review device labeling (Including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes.
Review and approve design and manufacturing changes for compliance with applicable regulations
Support quality system audits by notified bodies, government agencies and customers (if applicable)
Provide daily hands-on regulatory and quality internal support, RA service to clients
Comminication with Notified bodies
Change notification to Notified bodies
Coordination of activities with SUKL
Perform all other essential duties as assigned
Employee perks, benefits
- Flexibility
- Local Slovak manufacturer - no depandability on mother company / global procedures
- Local Slovak manufacturer - no depandability on mother company / global procedures
Information about the selection process
If you are interested in this position, please send us your CV in English language. We will contact suitable candidates only. Thank you for your understanding.
Please note that together with your application for employment, you are granting us your consent to the registration and processing of personal data under Act No 18/2018 Z.z. and Regulation (EU) 2016/679 (Zákon č.18/2018 Z.z. a Nariadenie (EÚ) 2016/679).
Please note that together with your application for employment, you are granting us your consent to the registration and processing of personal data under Act No 18/2018 Z.z. and Regulation (EU) 2016/679 (Zákon č.18/2018 Z.z. a Nariadenie (EÚ) 2016/679).
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Educational Specialization
lifescience, technical
Language skills
English - Advanced (C1)
Other knowledge
Microsoft Excel - Expert
Microsoft Word - Expert
Microsoft Word - Expert
Driving licence
B
Experience in the position/sector
Medical device
Number of years of experience
1
Personality requirements and skills
5+ years of experience with regulatory submissions and management of Class IIa, IIb disposable medical devices,
Regulatory affairs experience in writing US submissions and EU submissions and experience in collaboration and working with the Regulatory Authorities directly
Knowledge of FDA QSR's, ISO 13485, ISO 14971, ETO sterilization standard, packaging integrity standards
Regulatory affairs experience in writing US submissions and EU submissions and experience in collaboration and working with the Regulatory Authorities directly
Knowledge of FDA QSR's, ISO 13485, ISO 14971, ETO sterilization standard, packaging integrity standards
Advertiser
Brief description of the company
Sky Medical a.s. je technologický startup, ktorý sa zaoberá výlučne zdravotníckými pomôckami. Spoločnosť pôsobí v oblasti výroby jednorazových zdravotníckych pomôcok a poskytovania poradenských služieb v oblasti podnikania na trhu so zdravotníckymi pomôckami. Sky Medical a.s. je multikultúrna spoločnosť so zahraničným kapitálom. V spoločnosti vládne neformálna atmosféra čo vytvára predpoklad vybudovania mladého dynamického tímu ľudí, ktorých práca baví. Od členov nášho tímu očakávame kreativitu, nadšenie a samostatné myslenie.
Ak ťa baví kreatívna práca s inovatívnymi technológiami v zriedkavej pre Slovensko oblasti podnikania a neobmedzenými možnosťami osobného rozvoja, tento job je ideálny pre teba!
www.med-sky.com
Ak ťa baví kreatívna práca s inovatívnymi technológiami v zriedkavej pre Slovensko oblasti podnikania a neobmedzenými možnosťami osobného rozvoja, tento job je ideálny pre teba!
www.med-sky.com
ID: 3891289
Dátum zverejnenia: 27.1.2021
2021-01-27
lokalita: Remote work Pozícia: Regulatory Affairs Manager, Regulatory Affairs Specialist Spoločnosť: SKY Medical, a.s.
Základná zložka mzdy (brutto): 1 000 EUR/month