Affairs SpecialistDescription of the companyOur client is a leading company in a complex and highly environment and is currently looking for Affairs Specialist for a renewable temporary assignment.Description of the positionUnder 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 standardsOversee 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 product in affairs and/or in a scientific discipline relevant to human healthRelevant trainings/diplomas on medical devices [essential]/cosmetics [desirable]/food supplements/medicinal productsEXPERIENCEMinimum of 5 years of experience in Affairs- activities in life science industry, including product and support to product design & development projectsExperience in project management as project team vigilance management and framework survey in life science industryCOMPETENCIESKnowledge of EMEA applicable to :- Medical devices- Cosmetic products- foods/food supplements- commodity productsAnalytical skillsStrong interest in affairsAble to work in a multicultural environmentAbility to independently identify compliance risks and when necessaryProblem and proactiveTeam skillsFluent in English (both written and spoken)Computer literacy: MS Office jidb31e887aen jit0728aen jpiy26aen
Regulatory Affairs Specialist Arbeitgeber: ALBEDIS - GENEVE
ALBEDIS ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur ein dynamisches und unterstützendes Arbeitsumfeld bietet, sondern auch zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung. Mit einer starken Präsenz in der Schweiz und einem Fokus auf Luxus- und Lifestyle-Produkte profitieren Sie von einem inspirierenden Arbeitsklima, das Vielfalt und Innovation fördert. Hier haben Sie die Chance, Ihre juristischen Fähigkeiten in einem internationalen Kontext einzubringen und gleichzeitig Teil eines engagierten Teams zu werden.
