Scientific Affairs Manager 100%

Scientific Affairs Manager (all genders) 100% Chemistry, Process, Effect – everything from one source Borer Chemie AG is a globally active family business based in the Espace Mittelland. For over 60 years, we have stood for the highest competence in the demanding cleaning and disinfection of surfaces, instruments, and components. Our products are used wherever precise cleanliness is crucial: in hospitals, the Life-Sciences industry, medical technology, and demanding industrial applications. As an employer, we offer short decision-making paths and a lot of design freedom. Those who work with us contribute to something that matters with their expertise. For our Regulatory Affairs, Quality Management, and Scientific Affairs department, we are looking for a motivated, interested, independent, and cooperative person as Scientific Affairs Manager (all genders) • 100% available immediately or by agreement • permanent position • Borer Chemie AG, Zuchwil Your area of responsibility In this function, you will be directly subordinate to the Team Leader Regulatory Affairs and take on the following main tasks: Development and updating of the evidence base for product ideas and claims for product development, marketing, and sales (SOTA) Conducting and updating clinical and biological evaluations of medical devices in accordance with MEDDEV 2.7/1 Rev 4, MDR (EU 2017/745) and EN ISO 13485 Conducting and updating Post Market Surveillance including trend reporting (PMS plan, PSUR, PMS reports) in accordance with MDR (EU 2017/745) Conducting structured literature searches according to scientific reporting standards (e.g., PRISMA) and evaluating the evidence base for regulatory purposes Support in evaluating external expert opinions regarding efficacy or product performance Identifying the need for and coordinating external clinical studies and tests (PMCF, efficacy, procedures) Publishing specialist articles and actively participating in specialist associations (committees, standardization organizations) Your profile Natural science or technical basic studies (chemistry or biology) Experience with the quality management system (IMS) Regulatory and chemical expertise in ISO 9001 and ISO 13485 standards as well as medical devices Experience with clinical evaluations, literature searches, and evidence evaluations Experience in project management (planning, control, and implementation of projects) Knowledge of stakeholder management Writing scientific and regulatory reports, submissions, and publications Experience in document and process management (control, versioning, IMS administration, 4-eyes principle) Negotiation-secure German language skills (at least C1) and good English language skills (at least B2) Your benefits A diverse activity with exciting challenges Flexible working hours Various team events Participation in training and further education Participation in fitness subscription Discounted Reka checks Hot and cold drinks as well as break fruits Charging station for e-vehicles Questions about the position For technical questions, Dr. Hendrik Demuth, Director RQS, is available by email. Your next step Does this sound like your next challenge? Then we look forward to your application. Apply now Loepfe Team Leader HR Borer Chemie AG - Gewerbestrasse 13 - 4528 Zuchwil / Switzerland