Manager Diagnostics Regulatory Affairs(m/w/x)

In this role, you will navigate the complexities of regulatory affairs for diagnostic and medical device products, ensuring compliance while driving market access. Your expertise will be crucial in managing submissions and adapting to evolving regulations.

Anforderungen

• •Relevant higher education (Master's degree or PhD) or extensive professional experience (typically >5 years)
• •Proven experience in regulated, quality-controlled environments
• •Skilled in preparing and assembling regulatory documents
• •Solid understanding of the IVD development process
• •Knowledge of global regulatory/health authority guidelines and international standards
• •Proficient in MS Office with expertise in design control and validation studies
• •Proven ability to work independently and communicate effectively
• •Experience in communicating with international Health Authorities and fluency in English