Product Quality Assurance and Regulatory Compliance Manager
7 days ago
Job Summary
">As a Quality Assurance and Regulatory Affairs Specialist, you will play a vital role in ensuring the quality and regulatory compliance of our medical devices. Your primary responsibilities will include defining and delivering our strategy to maintain superior product quality, taking lead on placing our products on new markets, and becoming an expert in all corners of our Quality Management System.
Main Responsibilities
">- Co-driving product release projects in collaboration with the project manager from the development team.
- Supporting other departments in design control.
- Taking lead on the risk analysis for new products, with support from our clinical and development team.
- Reviewing and revising QMS procedures to ensure they are efficient and effective.
- Assisting management in prioritizing regulatory approval activities based on strategy and market potentials.
- Creating and coordinating the product submissions for the devices we develop (possibly supported by consultants).
- Training the company in QMS procedures.
- Participating in audits, both internal and external.
Requirements
">The ideal candidate will have at least 1 year of experience within quality assurance and/or regulatory affairs, a master's degree in healthcare, medical or life science, and excellent communication skills in English.
Benefits
">We offer a range of benefits, including flexible working hours, free coffee/tea, social gatherings, free office snacks, free Friday beers, and near public transit.
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