Junior RA/QA Officer

The QA/RA department is focused on obtaining approval for the commercialization of the products worldwide. The QA activities are focused on having an excellent QA system and its processes and has strong relations with Sales & Marketing, Product management and R&D.

Responsibilities:

• Coordinate, prepare, and follow up with international registration submissions (final product and intermediates), on time via partners as Marketing Authorization Holders.
• Act as liaison with partners and internal organizations to acquire required documentation for submission related to product changes and/or new product launches.
• Prepare/support international submissions with appropriate input/help from various functions (Regulatory Affairs, Commercial, Quality, R&D, etc.) in a timely manner.
• Assist with communication (e.g. prepare statements/justifications) or communicate directly with international regulatory authorities when needed.
• Ensure international Regulatory documents/records are complete, accurate and archived, and maintain an overview of submission status.
• Resolve questions/handle queries from international registration authorities in the context of international registrations by coordinating and collecting specific registration information with RA, Commercial, Manufacturing, QA, Medical and other applicable departments as necessary.
• Inform the internal organization of forthcoming changes in legislation and regulations and the possible impact on international registration dossiers.
• Responsible for writing and updating standard policies on an as-needed basis related to QA work.
• Responsible for execution of the QA audit plan

Your profile:

• Education on scientific level (Bachelor/WO)
• Pro-active, analytical, planned, and structured way of thinking
• Affinity with medical software
• Strong communicator
• Excellent knowledge of English language
• 3 to 5 year experience in the field of RA/QA

Please apply here: https://www.linkedin.com/jobs/view/3911016163

More information about our company and products is available on the web: www.piemedicalimaging.com. If you have questions about the job opening please contact Hester Bos ( hester.bos@esaote.com).