Your responsibilities

• As a Regulatory Specialist in Scope Fluidics you will be responsible for ensuring that all products comply with relevant international regulations and standards, including ISO 13485, MDR, and/or IVDR. Your duties will include preparing and maintaining technical documentation, coordinating product registrations and submissions, monitoring regulatory updates, and ensuring product labeling and marketing claims meet applicable legal requirements. You will collaborate closely with R&D, Quality, and other teams to support product development and lifecycle management. Additionally, you will contribute to post-market surveillance activities and act as a key liaison with regulatory authorities and notified bodies to facilitate timely market access and maintain compliance.
• • Preparation of technical documentation for IVDs & FDA various risk classes.
• • Post-marketing surveillance activities.
• • Participating in compliance / QMS audits.
• • Drafting / updating regulatory processes (procedures & records).
• • Occasionally contacting Notified Bodies.
• • Preparation of PMPFs.
• • Other, as per IVDR & FDA requirements.
• • Preferable: experience with FDA.

Our requirements

• Higher education in biotechnology, life and medical sciences, maths/physics, biomedical engineering, law or a related field.
• Documented minimum of 2 years of experience with regulatory compliance based on IVDR and/or FDA.
• Solid knowledge of IVD/MD requirements and related MDCG & IMRDF requirements.
• Attention to detail and ability to work independently, set task priorities, and meet deadlines.
• Proficiency in English (B2 or above) – note that all procedures and technical documents will be written in English, some team mates also speak English only.
• Experience with ISO13485.

Optional

• Experience with FDA.
• ISO13485 auditor training certificate.

What we offer

• Hybrid work model

• Flexible working hours

• A chance to work on impactful and meaningful scientific projects

• Learning opportunities within a skilled team