Technical Documentation Assessor for Active Medical Devices

Place of work
 Home Office / Slovak Republic

Contract type
Full-time / Part time

Starting date
ASAP

Salary
2 800 euro/brutto (depending on the experience of the candidate)

We offer: 

• Employment based on an employment contract full time / permanent
• Access to a package of employee benefits
• Opportunity for development and professional training
• Work in a group of specialists, in a company with an established position on the market
• Friendly atmosphere
• Necessary work tools
• Possibility to work remotely

Responsibilities: 

• Assessing Technical Documentation as part of product conformity assessments of Active Medical Devices according to the requirements of the Medical Device Regulation 2017/745
• Preparing reports included deficiency reports in case of non-conformities according to the requirements of the Medical Device Regulation 2017/745
• Delivering high-quality, reliable, and predictable services within defined timeframes
• Serving as an internal point of contact for TDA matters as part of the interfaces with other departments, offering support of and close exchange with colleagues
• Independent supervision of certification projects for our international customers as a project manager
• Readiness for intensive familiarisation with the ISO 13485, ISO 9001, MDR and MDSAP standards
• Optionally providing support during QMS audits of medical devices manufacturers according to ISO 13485
• Possibility of attending medical conferences

Qualifications: 

• University degree in technical or scientific studies, e.g. biomedical engineering, mechanical engineering, electronic engineering, electrical engineering, computer engineering or comparable field of study
• At least four years of professional experience in the manufacturing environment of the health care sector, e.g. with a manufacturer of medical devices
• At least two years of well-founded hands-on practical experience at design and development, quality management, manufacture, testing or regulatory affairs department is a plus
• Experience in creating or evaluating of technical documentation and for medical devices class III with the currently applicable product standards and regulatory requirements according to MDR
• Technical product knowledge in the field of medical technology
• Fluency in written and spoken English
• Proven qualification as an auditor or quality manger is a plus
• Excellent organisational and professional communication skills
• Ability to work in a team, pronounced customer orientation and good self-organization
• Curiosity and willingness to learn
• Experience working with MS Office applications and programs

Fill iin this short questionare and we will contact you!

EMPLOYEE PERKS, BENEFITS

• employment in a large international company
• pleasant working environment, professional approach of colleagues
• space for self-realization, personal growth, further education and training
• wide range of benefits - salary bonuses, language courses, Sick days, employer's contribution to pension savings

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Language skills:

• English - Advanced (C1)
• Highly proficient in spoken and written English. German language knowledge is a plus.

Other knowledge:

Mcrosoft Excel - advanced
Microsoft Word - advanced
Microsoft Outlook - advanced
Microsoft PowerPoint - basic

Number of years of experience:
4

INFORMATION ABOUT THE SELECTION PROCESS

Please send your CV in Slovak and English language. We will only contact selected candidates for a personal interview. We thank all the candidates for their interest in working for our company.

The basic salary and possibility of increase will be the subject of a personal interview depending on the professional experience and experience of the applicant. It is possible to work from home or from any of our branches e.g. Košice, Bratislava, Banská Bystrica, Nitra.

By sending your CV, motivation letter and other appendices related to the selection procedure, you give TÜV SÜD Slovakia sro, Jašíkova 6, 821 03 Bratislava, e-mail: [email protected], IČO: 35852216, responsible person (DPO): Ing . Katarína Matejčíková, e-mail: [email protected], consent to the processing of your personal data listed in the CV and the application for admission and other attachments related to the application for employment for the purposes of selection and registration in the internal database of candidates for employment in our company.
This consent is voluntary and is valid until revoked, but no longer than two years from its provision or until the date of signing the relevant employment contract / agreement on work performed outside the employment relationship with TÜV SÜD Slovakia s.r.o .., after this period they will be immediately liquidated.
The consent can be revoked at any time by sending a written revocation of the consent to the address of the registered office of TÜV SÜD Slovakia s.r.o .: Jašíkova 6, 821 03 Bratislava. The validity of the processing of personal data on the basis of this consent before the withdrawal of the consent remains unaffected.
At the same time, we inform you that according to § 19 par. 2 letter b), c) and d) of Act no. 18/2018 Coll. on the protection of personal data and on the amendment of certain laws, you have the right to request from TÜV SÜD Slovakia s.r.o. access to your personal data, the right to correct, delete and restrict the processing of your personal data, the right to object to the processing of personal data, the right to the transfer of personal data and the right to file a complaint (motion to initiate proceedings under Section 100 of Act No. 18/2018 Coll. z.) to the Office for Personal Data Protection of the Slovak Republic, with its registered office at Hraničná 12, 820 07 Bratislava 27, Slovak Republic, or to contact the Office via its website www.dataprotection.gov.sk.
The job seeker is responsible for the accuracy and veracity of the personal data provided to TÜV SÜD Slovakia s.r.o..

Send us your CV to [email protected]