Regulatory Specialist

Pracovní nabídka

REGULATORY SPECIALIST

Be part of a world-leading organization that is dedicated to improving lives through innovation in medical technology! In the area of smart solutions (Smart Care), we are looking for someone with a technical background and interest in this growing and high-potential field. As a part of our highly skilled regulatory team, you will be supporting the definition and execution of regulatory strategy and certifications for our entrusted product portfolio. This role involves also supporting product development and facilitating market entry, offering a unique blend of technical and regulatory challenges.

What are going to be your duties?

Coordinate planning and execution of product certifications with external test laboratories to ensure compliance and market readiness
Prepare and submit comprehensive regulatory documentation for product approval and registration across diverse markets, adhering to international standards
Proactively determine and implement regulatory requirements, providing continuous regulatory guidance and support throughout the product lifecycle, from initial concept to post-market surveillance – active medical device, radio equipment, Software as Medical Device (SaMD)
Collaborate in the development and review of product and technical documentation, guaranteeing regulatory compliance
 

What we think the right candidate should know, have....

High School or University Degree in a Technical field, such as Electro, Biomedical Engineering, or Information Technology
Solid understanding of radio and low voltage product design principles
Background in medical regulatory affairs, preferably within healthcare or medical devices (EU MDR, ISO 13485, MDSAP, …), is a benefit
Familiarity with software development methodologies and lifecycle management (IEC 62304, …), is a benefit
Written and verbal communication skills, including the ability to conduct formal presentations
Analytical skills to monitor regulatory, market, and development activities
English, with the ability to read, understand, and explain technical texts
Willingness to travel internationally (approximately 1-5 days per month) as part of collaboration with the development team based in Austria
 

What can we offer?

Working in a diverse team of product management enthusiasts

Working with premium products and be in close contact with development of new products

Great benefits (flexible working hours, cafeteria system, occasionally working from home, meal vouchers and company canteen, Multisport, language and other education, company kindergarten, 5 weeks of holidays etc.)
 

If you want to apply please send your CV.