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Product Specialist (MHS)

Budúcnosť máte vo svojich rukách

Place of work
Slovak Republic / Czech Republic / Home office

Contract type
Full-time

Starting date
By agreement

Salary
3 000 euro (depending on the experience of the candidate)
The full compensation package will be agreed after the training period


Job description and responsibilities

  • 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.

Employee benefits

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

Employee requirements

The position is suitable for candidates with education

  • 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
  • relevant Master degree substitutes one year and a relevant PhD degree substitutes up to three years of four years of work experience

Additional requirements

  • 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)

Education

  • Bachelor in e.g. electrical engineering, medical technology, physics

Language skills

  • Fluent English language - level C1 – necessary condition
  • German language knowledge is a plus

Other knowledge

Microsoft Excel – advanced
Microsoft Outlook - advanced
Microsoft Word – advanced
Power Point - advanced

Driving licence
B

Years of experience
Min. 4 years

Other personality requirements and skills

  • independence and flexibility
  • communicativeness, reliability
  • responsible approach to work tasks
  • organization skills
  • ability to learn new things quickly
  • systematicity

Information about the selection process

Job applicants please send CV in Slovak and English.

We will only contact selected candidates for a personal interview. We thank all the candidates for their interest in working for our company.

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 grant 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 revoking 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]

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