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Senior Associate RA EMEA

Req #: 180005BZ_en
Location: Munich, BY DE
Job Category: Regulatory Affairs
Date Posted: 4/17/2018 8:48:27 AM
Baxter International

Description

  • Responsibility for all regulatory aspects of the CE marking process for assigned medical devices with emphasis on regulatory compliance and life cycle maintenance. In particular responsibility for Renal Disposable devices
  • Responsibility for preparation of relevant registration files like STED or technical files (e.g. or variation or renewal files) for the area of European Union and related to the Medical Device Directive 93/42/EEC (MDD) and future Medical Device Regulation (MDR), in close collaboration with the different functions involved
  • Responsible for the preparation of relevant documentation needed to support CE marking activities for countries outside of the EU where CE marking is basis for country registration
  • Collaborate with global regulatory counterparts to develop global/regional/country regulatory strategy
  • Provide guidance to project teams in the area of design and analysis for more straightforward projects
  • Proactively interact and negotiate with regulatory agency project review teams to ensure positive outcomes for submission
  • Educate internal stakeholders on implications of regulations
  • Plan, coordinate, prepare, and execute formal meetings with regulatory agencies
  • Facilitate the identification of risk elements for specific projects to get early indication of areas of risks

Qualifications

  • Degree in engineering of life science and good knowledge of CE marking of medical devices (MDD 93/42/EEC and related directives and guidelines)
  • 3-5 years of work experience in the area of medical device regulatory affairs in a medtech company necessary
  • Ability to liase with different functions involved in the elaboration of CE-marking files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics
  • Ability to interpret European regulations and guidelines and all technical product information in order to assure that regulatory requirements in the area of medical devices are continuously met
  • Excellent organizational skills including project management skills
  • Experience in collaboration with international teams and strong commitment to teamwork, quality and customer satisfaction
  • Excellent written and verbal communication skills in English; knowledge of any other European language, in particular German is desired
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