Medical Devices RA Specialist

SKY Medical, a.s.

Place of work
Remote work
Contract type
full-time, part-time, agreement-based (Temporary jobs), trade licence
Start date
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)

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

Employee perks, benefits

- Flexibility
- 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).

Expected date of completion of the selection process

1 May 2021 (there are still 60 more days)

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

lifescience, technical

Language skills

English - Advanced (C1)

Other knowledge

Microsoft Excel - expert
Microsoft Word - expert

Driving licence

B

Number of years of experience

Medical device
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

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

Company address

Sky Medical a.s.
Vicenzy 24
93101 Šamorín
ID: 3891289  Dátum zverejnenia: 27.1.2021  Základná zložka mzdy (brutto): 1 000 EUR/month