Technical documentation accessor

Job Description

YOUR TASKS

 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.

 

YOUR QUALIFICATIONS

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 (2 nights/week in a hotel in average)

 
Get Jobs Like This By Email

Contact

Cosmin Cucu
+ 40 21 411 6114
Romania