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Quality Assurance – Regulatory Affairs Expert Amaris in GERMANY

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Germany

NA

2020-12-10

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Quality Assurance – Regulatory Affairs Expert Amaris in GERMANY

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been implementing solutions in major projects for over a decade – this is made possible by an international team of 7000 people from 95 different nationalities, spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering.    We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential.

Your Role

Amaris Consulting is looking for a talented Quality Assurance/Regulatory Affairs expert to join our ever-growing team from Germany.

 

Responsibilities

  • Implement all Regulatory and Quality Assurance activities according to procedures and regulatory requirements.
  • Provide oversight to ensure that the company is 100% compliant with international regulatory requirements.
  • Review product design for compliance with engineering principles, company standards, and customer contract requirements, and related specifications.
  • Monitor and continuously improve the Quality system by evaluating supporting documentation to ensure compliance to Industry standards, and other applicable regulations.
  • Work with other team members to develop, document, and validate functional requirements and user requirements for electronic quality processes.
  • Attend relevant briefings, presenting the outcome and providing reviews and assessments, orally and in writing, in a timely manner.
  • Assist in the design, development, and implementation of an electronic document management system that will manage (i.e., draft, edit, and approve) documentation, as well as serve as a repository for approved documents with search and retrieve capabilities.
  • Perform product testing and failure analysis, data logging of quality data and trend results.
  • Perform other duties as assigned.

 

Requirements

  • Bachelor’s Degree in a scientific/engineering field; Master of Science preferred.
  • Minimum 5 years of experience in the medical device industry.
  • Minimum of 3+ years’ experience in Regulatory Affairs, Engineering, Quality Assurance.
  • Proficiency in English (other languages would be a plus).

 

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