Quality and Regulatory Affairs Manager

at  Paratus People

Deutschland, , Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate08 Jul, 2024Not Specified09 Apr, 2024N/AIso,Communication Skills,Cfr,Medical Devices,Regulatory AffairsNoNo
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Description:

REQUIREMENTS:

  • Proven experience with managing QM systems in accordance with ISO related to med-tech such as 13485, ISO 14971 (or ISO 9001) and FDA
  • Experience with regulatory affairs for medical devices and QMS
  • Knowledge of, or experience with, in-vitro diagnostic medical devices regulation (MDD / MDR) IVDR and CFR
  • Exceptional communication skills, attention to detail and project management experience or knowledge

Responsibilities:

DUTIES:

  • Take care of the implementation and maintenance of a Quality Management System (QMS) that complies with ISO 13485, ISO 14971, IVDR and FDA 510(k)
  • Ensure that the processes and products meet all necessary quality and regulatory requirements before they reach the users
  • (In English, though it could also be in German) Communicate with Notified Body and other responsible authorities
  • Ensure documentation is always kept up-to-date

REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Deutschland, Germany