For our client, a Medical Device company which produces biomedical laboratory instruments, we are currently looking for this permanent position in Munich:

Senior Analyst, Regulatory Affairs (m/f/d)

Vertragsart: Festanstellung

Auftragsnummer: A527-828

Startdatum: 01.03.2019

Einsatzort: München


Ihre Aufgaben:

  • Working within the Workflow and IT Solutions (WITS) Quality RA organization, the Senior Analyst Regulatory Affairs reports directly to the WITS Manager, Regulatory Affairs.
  • He/she ensures compliance of the products and the regulatory processes and supports Automation and Informatics product lines. 
  • Ability to work in a matrix and multicultural environment to drive improvement and simplification.
  • Ensures product and processes compliance.
  • Defines product registration strategy and drives communication with competent authorities.
  • Supports new product development as RA Core Team member.
  • Supports post launch design change process.
  • Coordinates post market regulatory activities.
  • Drives improvement of local and global processes associated to regulatory.

Ihre Qualifikationen:

  • Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
  • Successful experience in pre and post-market regulatory affairs in Medical device/IVD industry of 7 years +
  • Excellent communication skills and team work.
  • Excellent practical experience of IVD regulations including but not limited to US, EU, Canada, and China.
  • Strong risk management experience per ISO14971.
  • Knowledge of IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304, and software cyber security and privacy is a plus.
  • Experience in post market activities; recall management and adverse event reporting.
  • Experience in post launch design changes.
  • Ability to work cross culturally/functionally and understand functional department requirements.
  • Proficient in English.
  • Excellent organizational capabilities.
  • Highly ethical, is able to multi-task and prioritize in a competitive environment.
  • Computer skills (MS Office products).
  • Clean driving record – ability to travel as required (may include international travel).