IVD / IVDR Advisor

As an IVD / IVDR Advisor at Platomics you will:

• You will be at the forefront of IVD / IVDR compliance, guiding diagnostic laboratories through the complex landscape of regulatory standards such as ISO 15189 and IVDR. Your experience in the diagnostic laboratory domain and expertise in regulation and quality management systems (QMS) will be crucial as you leverage Platomics' cutting-edge automation platform to streamline technical documentation, Standard Operating Procedures (SOPs) , Electronic Quality Management Systems (eQMS) functions, and risk management processes. You'll provide expert advice through workshops and individual sessions on implementing the necessary processes and verifications, utilizing digital automation solutions to help our laboratory customers efficiently create documentation and achieve regulatory compliance with standards like ISO 15189, ISO 22367, and ISO 5649. Your role will involve staying abreast of the latest regulatory changes and technological advancements, contributing to the development of Platomics' services, and ultimately making a significant impact in the world of IVD compliance as part of our dynamic, forward-thinking team.

What you bring to the table

• Comprehensive knowledge of ISO 15189, IVDR, and quality management systems for diagnostic laboratories.

•  5+ years of experience in IVD regulation (with detail in InHouse), and/or lab experience - ideally with lab developed tests

• Strong risk management skills

• Exceptional project management and organizational skills, enabling you to effectively handle complex tasks, manage necessary interactions with our customers and consistently meet deadlines.

• Strong ability to explain complex technical and regulatory concepts in a clear, understandable manner

• Strong written and oral English communication skills

• A talent for building and maintaining strong client relationships.

• A proactive, solution-oriented approach to problem-solving.

• A degree in Life Sciences or a related field

• Comfort and efficiency in working within a fully digital, paperless environment.

• Willingness to travel up to 30%

Nice to have

• Proficiency in one or more additional languages such as German, Italian, or French

• Prior client-facing experience

• Proficiency in advanced diagnostic techniques such as Next-Generation Sequencing (NGS) or Immunohistochemistry (IHC)

As a distributed team, we aim to create opportunities for people to work to their full potential whether that is in our headquarters in Vienna, Austria or in a remote location. The role is open to applicants based anywhere in Europe.

What we offer

• Work in a company that has a truly meaningful impact: with our work, we will improve healthcare for millions of people

• Competitive salary: Offers in accordance with Austrian collective bargaining agreements. However, our salaries are market oriented and in line with your qualifications and experience.

• Flexible working hours: Because you know best when it is the best time to do your work

• Remote flexibility: Join us in Vienna or from your home office anywhere in Europe

• Workcation: Ability to work abroad for limited periods

• Tech pack: We provide individual hardware for your success

• Regular in-person events: At our headquarters in Vienna as well as team-building budget

• Counseling: Confidential and professional service to support our team

• Discounts: For onsite staff there are discounts at the grocery store, pharmacy and the gym to keep body and mind healthy

What happens next

If this posting sparked your interest, please submit your application below. You can familiarize yourself with the company via our website and Linkedin page.

If your skillset matches what we are looking for, you will be contacted and the application process follows these steps:

1. Introductory Call (30 min)

2. Home Task

3. Presentation and Discussion (90 min)

4. Team interview (60 min)