Scientific Affairs Manager

We are looking for a motivated person as Scientific Affairs Manager (m/f/d) 100% in Zuchwil, SO. Scientific Affairs Manager Your tasks Development and updating of the evidence base for product ideas and claims for product development, marketing and sales (SOTA) Conducting and updating the clinical and biological evaluation of medical devices according to MEDDEV 2.7/1 Rev 4, MDR (EU 2017/745) and EN ISO 13485 Conducting and updating the Post Market Surveillance incl. trend reporting (PMS plan, PSUR, PMS reports) according to MDR (EU 2017/745) Conducting structured literature searches according to scientific reporting standards (e.g. PRISMA) and evaluation of the evidence base for regulatory purposes Support in the evaluation of external expert opinions regarding efficacy or product performance Determination of requirements and coordination of external clinical studies and tests (PMCF, efficacy, procedures) Publication of technical articles as well as active participation in professional associations (committees, standards associations) Your profile Scientific or technical undergraduate studies (chemistry or biology) Experience with the quality management system (IMS) Regulatory and chemical expertise of the standards ISO 9001 and ISO 13485 as well as with medical devices Experience with clinical evaluations, literature searches and evidence evaluations Experience in project management (planning, controlling and implementation of projects) Knowledge in stakeholder management Writing of scientific and regulatory reports, submissions and publications Experience in document and process management (control, versioning, IMS administration, four-eyes principle) Business fluent German skills (at least C1) as well as good English skills (at least B2) jpide814b1ejm jit0730jm jiy26jm