Device Compliance and Regulatory Specialist
2 days ago
At Radiobotics, we believe that quality assurance and regulatory compliance are essential to delivering high-quality medical devices. As a regulatory affairs expert, you will play a vital role in ensuring our products meet the highest standards of quality and safety.
In this role, you will work closely with the development team to drive product release projects and support other departments in design control. You will also take lead on the risk analysis for new products and review and revise QMS procedures to ensure they are efficient and effective.
Your expertise in quality management systems and regulatory requirements within MDR and ISO 13485 will be essential in creating and coordinating product submissions for the devices we develop. Additionally, you will train the company in QMS procedures and participate in audits, both internal and external.
To be successful in this role, you should have at least 1 year of experience within quality assurance and/or regulatory affairs, with knowledge of working with quality and regulatory processes within the medical device field.
The ideal candidate will have a master's degree in healthcare, medical or life science, a positive can-do attitude, excellent communication skills in English, and experience with working within or leading cross-functional projects.
We offer a competitive salary, flexible working hours, and opportunities for professional growth and development. If you are passionate about regulatory affairs and quality assurance, we encourage you to apply.
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