QA/RA Associate

FLUIDDA is the world leader in the field of Functional Respiratory Imaging (FRI). FRI combines HRCT scans, Artificial Intelligence Algorithms and Computational Fluid Dynamics technology, offering vast improvements by making clinical trials shorter, faster, and thus, more cost effective. We are currently seeking a QA/RA Associate I in Europe to join our Team, the position is on-site / remote.

Mission – expected permanent results
Along with the QA Officer, improve and maintain compliance of FLUIDDA’s quality management
system with regulatory requirements. Assist in drafting global medical device regulatory
submissions and in maintaining compliance of the current devices with applicable regulatory
requirements.

Duties and responsibilities
The QA/RA ASSOCIATE I
• Provides assistance in creating medical device regulatory submissions for markets
including USA, UK, Canada, etc. and in maintaining Design History Files and Technical
Documentation for certified devices.
• Handle change controls
• Assists the QA Officer & Regulatory Affairs Specialist to obtain and maintain ISO 13485 &
CE certification from the notified body
• Participates in audits performed by external clients or regulatory bodies
• Provide assistance in handling and resolving nonconformities and CAPAs
• Conducts some of the quality system related reviews scheduled in the quality plan
• Handles onboarding of new employees
• Serves as Deputy Person Responsible for Regulatory Compliance – Perform
responsibilities of PRRC as listed in and in the absence of Regulatory Affairs Specialist
Required Skills & Education
• Interpersonal skills
• Good computer skills
• Excellent communication skills in written and spoken English
• Pro-active and flexible
• Schedule flexibility to travel as needed
• Strong administrative skills
• Independent working
• Adaptability in a work environment
• Works well with a team
• Bachelor’s degree in Law, Medicine, Pharmacy, Engineering or another relevant scientific
discipline
Desired experience
• 0-1 year work experience in the quality/regulatory department of a regulated
industry OR equivalent educational qualifications
• experience in clinical trials is a plus
FLUIDDA offers a competitive salary and supplementary benefits in accordance with the
required level of experience
Job Type: Full-time – Contract

Please send your applications to:
vacancies[at]fluidda.com


Categorised in: / May 9, 2022 2:46 pm / Published by