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PRODUCT MANAGER - Echipamente medicale

Job Description

Scope of the role:

This is a regional role, part of a major expanssion of an important project consists in new division that will serve CEE/SEE countries. 


 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.



* 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)

We wellcome other EU nationalities, in which case they could choose to work in their home countries /region where our Client have an office.

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Irina Vasile
Tel & Fax: + 40 21 411 6114

Tel: +40723165580