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PRODUCT and REGULATORY SPECIALIST

 

For a successful international company working in the field of medical technology based in Slaný, we are looking for a Product and Regulatory Specialist.  

In the area of Digital Health solutions (Smart Care), we are looking for someone with technical background and long-term interest in this growing and high potential field.

 

 

What will you do:

  • Following and implementation of business segment strategy
  • You will take care of products in the field of IoT Applications, HW, connectivity, cybersecurity, health data exchange, wireless communication of any form (e.g., Wi-Fi, Bluetooth, NFC)
  • You will work with general regulatory requirements and standards within digital healthcare
  • Management of the product portfolio throughout the product life cycle
  • Monitoring, evaluation and implementation of relevant product specification and regulations, standards, norms and guidance into product development
  • Cooperation on collection and definition of design inputs – interconnection of LINET standard portfolio with digital healthcare (SmartCare)
  • Responsibility for management of technical documentation for entrusted products
  • Support product field testing, clinical evaluation and clinical trials
  • Responsibility for maintenance of product specification in LINET systems and tools
  • Support of product launch through preparing data in LINET systems for ordering, pricing etc.
  • Responsibility for maintenance of data for price lists
  • Responsibility for data collection and evaluation from post-marketing surveillance

 

 

What we think the right candidate should look like:

  

  • High School or University Degree in Technical field,
  • Written and verbal communication skills, including formal presentation skills
  • Ability to work in multinational teams, skills to effectively deal with a variety of strong personalities within the workplace
  • Analytical skills and common sense
  • Big plus is experience in regulatory and/or product management
  • Project management skills
  • To be interested in IT and have knowledge of the process of SW development, ideally including agile development
  • Very good English (ability to read, understand and explain technical text in English) and very good knowlede of Czech

 

 

What we offer:

  • Interesting and responsible work for leading technological international company
  • Being part of a successful and still growing company with worldwide coverage
  • Competitive salary and broad scale of benefits (extra days of holidays, flexible working hours, home office, canteen, 13th salary etc.)
  • Professional education and development
  • Start of the work: autumn 2022
  • Location: Želevčice, Slaný

 

 

If you are interested, please, click on Apply Now and send your CV in English.

 

 

 

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