Beschreibung

ALBEDIS is a leading Swiss recruitment partner, specializing in connecting talent and companies across a wide range of sectors, from support positions to management functions. Member of Interiman Group, ALBEDIS relies on the combined expertise of its partner brands to cover areas such as architecture and real estate, finance, IT, life sciences, legal, or human resources, with a presence throughout Switzerland.Description of the companyOur client is a leading company in a complex and highly environment and is currently looking for an Affairs Specialist - MDR for a renewable temporary assignment.Description of the position- Under supervision, compile, and submit to competent authorities, notified bodies, agencies, and business partners, including the of key market documents, including technical with Regional Head of Affairs to ensure rapid and timely approval of new products and continued support of products marketed within and outside the Europe, including labelling guidance and deliverables required for technical file and MDR to support and ensure compliance across Europe for a broad product portfolio including medical devices, consumer packaged goods, and with the development of the Europe with functional partners and contribute to business and make for projects by working closely with R&D and marketing departments to move projects from supervision, proposed product for domestic and impact, completing assessments as needed in change control compliance with applicable Europe and standards- Oversee MDR and complaints; submit adverse events to the EU authorities and assess impact on other markets.- Prepare necessary outlines, summaries, reports, memos, graphs, charts, tables, and supervision, prepare responses to health authority questions and other correspondence.- Ensuring the maintenance of policies and procedures in quality management EDAMED for Unique Device Identifiers as products are added and discontinued.- Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for and approve promotional and labelling for impact to productin affairs and/or in a scientific discipline relevant to human health- Relevant trainings/diplomas on medical devices [essential]/cosmetics [desirable]/food supplements/medicinal productsEXPERIENCE- Minimum of 5 years of experience in Affairs- activities in life science industry, including product and support to product design & development projects- Experience in project management as project team- vigilance management and framework survey in life science industryCOMPETENCIES- Knowledge of EMEA applicable to :- Medical devices- Cosmetic products- foods/food supplements- commodity products- Analytical skills- Strong interest in affairs- Able to work in a multicultural environment- Ability to independently identify compliance risks and when necessary- Problem and proactive- Team skills- Fluent in English (both written and spoken)- Computer literacy: MS Office jidba69d4faen jit0832aen jpiy26aen