The Opportunity

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US and Europe operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

• Support the R&D unit with the authoring and preparation of documents connected to product development/design control and validation documents, responses to regulatory questions, briefing documents
• Collaborate with multidisciplinary teams to understand different aspects of the product development and bring that knowledge to drafting regulatory and design control documents that conform to industry standards, and accepted templates.
• Manage review of regulatory and design control documents; ensure the accuracy, adequacy, and consistency of documents.
• In collaboration with Regulatory leads, participate in the development of study timelines for regulatory documents.
• Assist with process development initiatives to meet internal needs.
• Develop, improve, and implement document templates

What you'll bring

• Bachelor's degree required. Advanced degree in chemistry, biochemistry, material science, bioengineering, molecular biology, or genetics preferred
• 3+ years' experience as a technical writer in relevant industry, (biotech, medical device, scientific equipment) focused on scientific or regulatory writing or the equivalent
• Experience writing documentation for IVD product development projects
• Ability to understand and communicate scientific information effectively with colleagues from a variety of disciplines, including biological, bioinformatics, software development, clinical, nonclinical, and quality subject matter experts
• Previous experience with working on software-rated documentation is a plus
• Attention to detail
• Knowledge and experience with time management and timeline development
• Flexibility
• Excellent oral and written communication skills in English
• Ability and willingness to travel 25% of the time.

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