Technical Documentation Accessor

Work Service

Place of work
Bratislava region (The job requires travelling)
Contract type
full-time
Wage (gross)
From 2 500 EUR/month

Information about the position

Job description, responsibilities and duties

Assessment of Technical Documentation: Perform conformity assessments of regulatory submissions such as Design Dossiers and Technical Documentations to relevant safety principles and standard requirements.
Auditing (to limited extent): Perform regulatory audits of clients per European Medical Device Regulation (MDR), Medical Device Single Audit Program (US, Canada, Brazil, Japan, Australia), and International quality system standards (e.g. ISO 13485) as well as internal Notified Body criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.
Project Management: Provide project management for customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.
Communication / Customer Service: Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.

Information about the selection process

Minimum BSc degree in biomedical, electrical, or mechanical engineering or equivalent
Four years’ experience in medical device industry and two years’ work experience in design / product development / manufacturing engineering one of the following medical device product categories: Active Implantable Medical Devices, Ophthalmology, wound care products, Cardiovascular products, Absorbable Implantation Products, Functional Safety and Software
A relevant Master degree substitutes one year and a relevant PhD degree substitutes up to three years of four years of work experience
Sound knowledge in regulatory requirements, e. g. MDR (REGULATION (EU) 2017/745) and other related requirements
Sound knowledge in product-, technology- quality- or other related standards
Orientation towards the safety and performance of medical devices
Correctness
Ability to work in an intercultural environment
Ability to plan and organize work
Proficiency in MS Office
Common sense and pragmatism
Auditor according to ISO 13485 and MDR and CMDCAS and JGMP (a plus)
Sound knowledge in product-, technology- quality- or other related standards
Willingness to travel up to 20% (domestic and international)

Company on whose behalf the position is being filled

Hospitals, medical practice activities, other human health activities

A global leader provider of quality, safety and sustainability solutions that specialises in testing, inspection, auditing, certification, training and knowledge services.

Requirements for the employee

Candidates with education suit the position

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

Language skills

English - Proficiency (C2)

Driving licence

B

Number of years of experience

Medical Devices
4

Advertiser

Brief description of the company

Společnost Work Service byla založena v Polsku v roce 1998, jako reakce na vzrůstající poptávku po pracovních silách. V současné době jsme jednou z největších společnotí zabývající se náborem pracovních sil a zajišťováním dočasných pracovníků ve střední a východní Evropě a zaměstnáváme tisíce lidí. Vedoucí postavení na polském trhu práce byl startovní můstek pro mezinárodní expanzi. Nyní působíme v 10-ti evropských zemích: Česká republika, Polsko, Slovensko, Německo, Anglie, Irsko, Ukrajina, Holandsko, Belgie

The company is a holder of a licence to offer recruitment services.

Number of employees

1000 and more employees

Company address

Antal International s.r.o.
Anglická 140/20
120 00 Praha 2
Czech Republic
http://www.workservice.cz

Contact

Kontaktná osoba: Monika Volčková
E-mail: poslať životopis
ID: 3997745  Dátum zverejnenia: 9.11.2020  Základná zložka mzdy (brutto): 2 500 EUR/month