Career

Responsibilities:

• Active participation in creating and updating technical documentation for IVD product according to EU IVDR/ USA FDA requirements
• Gap analysis between the documentation and related regulations, with suggestions for improvement
• Compilation and submission of technical documentation required for registration
• Cooperation with regulatory parties such as authorities, certification and notified body
• Participation in product registration applications
• Prepares and coordinates completion and filing of Post Market Surveillance documentation, Field safety Corrective Action, Adverse Event Reporting
• Representing Quality/Regulatory on project teams throughout the product development cycle, providing feedback and guidance

Expectations

• College or university degree Experience in regulatory affairs within medical device (MD) or in-vitro medical device (IVD) industry
• Proficient in English language (business professional level)
• High precision
• Good oral and written communication skills
• Assertiveness
• Ability to work independently
• Open to embracing modern state-of-the-art technologies

Advantages

• Experience in the operation of the ISO13485 quality management system
• Proficiency in audits by regulatory bodies such as notified bodies

What we offer

• A long-term perspective
• A team of young, ambitious and dynamic professionals offering exceptional support to enhance your talents and potential
• Clear, flat hierarchy and a supporting company culture, quick feedback and short decision-making processes
• Ability to grow together with the company
• Extensive travel worldwide
• Flexible work schedule

Working hours: Full time