At Oro Clean Chemie AG, we believe leadership doesnt come from behind a desk. As a family-owned Swiss manufacturer with over 50 years of expertise in infection prevention, we develop and produce high-quality disinfectants for healthcare professionals around the world. With distribution in over 60 countries and subsidiaries in the Czech Republic and Malaysia, we combine global reach with the agility of a compact, innovation-driven company.
We are seeking a hands-on professional to lead our R&D and Quality Management activities. This is not a purely managerial positionwe are seeking someone who actively contributes and takes ownership across key functional areas. You will be responsible for formulating new disinfectant products, designing and executing test protocols, preparing and maintaining Safety Data Sheets (SDS), and validating transport conditions for dangerous goods under IATA, ADR, and IMDG. Additionally, you will manage technical documentation for CE-marked medical devices and biocidal products, lead regulatory submissions, and liaise directly with Notified Bodies and authorities. Working closely with a small, capable team, you will oversee product development, regulatory compliance, and the companys quality systems in accordance with ISOand ISO
Position Summary
In this multifaceted leadership role, you will oversee Research & Development, Regulatory Affairs, and Quality Managementnot just by planning and supervising, but by directly executing critical technical tasks. You will be personally involved in formulation development, technical documentation, analytical support, and global regulatory submissions.
As the companys Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR and internal auditor, you will ensure compliance with all applicable regulatory obligations related to medical devices. In addition, you will oversee regulatory compliance for biocidal products in accordance with BPR and other international frameworks. You will also be responsible for the creation and maintenance of Safety Data Sheets (SDS) and for ensuring proper classification, labelling, and transport of hazardous goods under IATA, ADR, and IMDG regulations.
You will support and ensure product compliance across key regulatory frameworks, including:
Candidate Profile
To succeed in this role, you are a proactive, detail-oriented expert with the ability to balance strategic oversight and hands-on execution. You thrive in a dynamic environment and are comfortable wearing multiple hatsscientist, auditor, author, communicator, and problem solver. You are confident working independently while collaborating closely with colleagues across departments and external stakeholders. You adapt quickly to changing regulations, manage ambiguity with confidence, and enjoy working in a fast-moving, lean organization where your decisions directly impact the companys success.
Required Qualifications and Experience