RAQM Engineer

Regulatory Quality Engineer

Join a world-leading company in MedTech, who are working in the field of cancer detection & treatment, as they search for a new team member to support the Quality & Regulatory Affairs activities.

You will join a strong team, have varied and interesting projects, and support with the following tasks:

Responsibilities:

• Coordinating, executing, and endorsing international regulatory product clearances and registrations 

• Compiling documentation and approval dossiers for new items while keeping in mind applicable laws and guidelines

• Assisting development teams in making sure pertinent standards are followed

• Assist with engineering and service teams in all quality-related matters

• Assist with process and product enhancements

• Upkeep and future advancement of the QM system

• You have a great deal of freedom to reshape the environment, become involved in new areas, alter processes, and bring new approaches

Experience required:

• A degree in the medical or scientific field (or equivalent)
• 3-5 years of experience in Regulatory Affairs and/or Quality Management in the medical technology field
• Ideally, you bring experience with active medical devices or medical software
• Fluency in English and German
• Knowledge of regulatory requirements and medical device relevant standards (e.g. ISO 13485, EU-MDR, ISO 14971)

If you're interested in this position, please apply here and/or contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com

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