Head Of R&d And Quality Management

Oro Clean Chemie AG

  • Fehraltorf, Zürich
  • Unbefristet
  • Vollzeit
  • 24 Tage her
At Oro Clean Chemie AG, we believe leadership doesn’t 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 position—we 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 company’s quality systems in accordance with ISOand ISOPosition SummaryIn this multifaceted leadership role, you will oversee Research & Development, Regulatory Affairs, and Quality Management—not 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 company’s 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:
  • Regulation (EU) 2017/745 – Medical Devices Regulation (MDR)
  • Regulation (EU) 528/2012 – Biocidal Products Regulation (BPR)
  • Regulation (EC) No 1907/2006 – Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
  • Regulation (EC) No 1272/2008 – Classification, Labelling and Packaging of Substances and Mixtures (CLP)
  • ISO:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • ISO 9001:2015 – Quality Management Systems – Requirements
  • ISO/IEC:2017 – General Requirements for the Competence of Testing and Calibration Laboratories
  • Global regulatory requirements for chemical disinfectants and medical devices in key markets including Taiwan, Malaysia, Singapore, and others
  • Transport compliance regulations including: (1) ATA – International Air Transport Association (Air Transport of Dangerous Goods), (2) ADR – European Agreement concerning the International Carriage of Dangerous Goods by Road, (3) IMDG – International Maritime Dangerous Goods Code, (4) Including validation of transport stability and proper packaging of hazardous materials
Candidate ProfileTo 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 hats—scientist, 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 company’s success.Required Qualifications and Experience
  • Extensive professional experience in the medical device, disinfectant, or related regulated industry-typically 10+ years, with at least 5 years in a senior or cross-functional leadership role
  • Proven, hands-on involvement in: (1) Formulation development and test design for disinfectants or similar products, (2) Design History File (DHF) creation and maintenance according to ISO, (3) Technical documentation creation and maintenance under EU MDR and/or BPR, (4) Safety Data Sheet (SDS) creation and chemical classification under CLP, (5) Transport of dangerous goods (air, road, rail)
  • Experience with: (1) Post-market surveillance, risk management, and clinical evaluations, (2) Communication with Notified Bodies, Competent Authorities, and third-party laboratories, (3) Performing internal and external audits
  • In-depth knowledge of applicable regulatory frameworks and standards: (1) Regulation (EU) 2017/745 – Medical Devices, (2) Regulation (EU) 528/2012 – Biocidal Products, (3) REACH, CLP, and international transport regulations (IATA, ADR, IMDG), (4) ISO, ISO 9001, ISO/IECand Good Distribution Practice for Medical Devices
  • Excellent English skills (minimum C1); German or Mandarin is an advantag
Relevant Training and CompetenciesWe value documented competence and practical experience. While formal certifications are an advantage, they are not mandatory if equivalent knowledge and performance can be demonstrated.Candidates should ideally have completed training or possess experience in the following areas:
  • ISO:2016 – Lead Auditor qualification (IRCA or equivalent)
  • EU MDR 2017/745, including: (1) Technical documentation (Annex II & III), (2) Clinical evaluation (Annex XIV), (3) Risk management (ISO), (4) Post-market surveillance (PMS) and vigilance, (5) PRRC responsibilities under Article 15
  • Medical Device Single Audit Program (MDSAP) including its structure, audit process, and nonconformity grading system
  • Biocidal Products Regulation (EU) 528/2012 and related dossier requirements
  • REACH (EC 1907/2006) and CLP (EC 1272/2008) compliance and SDS authoring
  • Dangerous Goods Transport Regulations: (1) IATA (air transport), (2) ADR (road transport), (3) IMDG (sea transport), (4) Packaging, labelling, and validation of transport stability
  • Applied hygiene, microbiology, and virology in the context of disinfectant efficacy evaluation
  • Various types of validation in medical device manufacturing including process, cleaning, and transport validation in accordance with ISOand EU MDR 2017/745
  • Analytical method validation (e.g. gas chromatography, titration, viscosity, pH, stability testing)
What We Offer
  • Competitive compensation aligned with experience
  • Comprehensive health and social benefits
  • Opportunities for further training and professional development
  • A key leadership role with strategic influence
  • A chance to drive innovation and compliance in global infection prevention
Ready to lead with purpose and precision?If you're looking for a role where you can make an immediate impact and be involved in everything from development to compliance — we’d love to hear from you. Please send your CV, a motivation letter, and copies of relevant certifications by email to . jid16cafd1a jit0832a jiy25a

Jobs.ch