We are Straumann.
United for global excellence in dentistry.
Every vision has its story. Ours began more than 60 years ago. Since then our innovations and achievements have become landmarks in dentistry worldwide. Straumann began as a family-owned institute, grew into a publicly owned holding, and today comprises a number of international companies around the world.
The Straumann Group develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics and biomaterials for use in tooth replacement and restoration solutions or to prevent tooth loss.
We are looking for a Senior RA Manager Global Project Management (m/f) to coordinate the monitoring of regulatory projects related to new products, line extensions, life cycle products or selected products from partner companies for the entire Straumann portefolio (SDIS, Digital and Biomaterials).
YOUR TASKSOrganize and communicate on a regular basis the progress of the registration projects for Europe, North America, EMEA, LATAM, and APACEnsure that internal processes and metrics are aligned to create highest visibility with our department CSE (Customer Solutions and Education) and the corresponding commercial regionsCoordinate and determine in collaboration with CSE the priority definition for launches of new products or line extensions in the various countriesAssist where necessary in definition of RA strategy of new product registrations in strategic markets such as APAC or LATAM in order to minimize cost and time for registrations based on the global marketing planReview the RA strategies for the most important projects and work in collaboration with the corresponding RA teams on the most promising and fastest routes to achieve product clearanceProject management for RA process improvement based on Lean approachParticipate in review of submissions for high profile projectsBuild strong relationships with RA&C Managers for SDIS, Digital, Biomaterials and International RA ManagersClosely monitor appropriate metrics in order to track regulatory and process improvements. Build an efficient network to define and achieve objectives
YOUR PROFILE Master degree in engineering or natural science5+ years expertise in Regulatory Affairs with international experienceSignificant experience in project managementExpert understanding of international medical device regulations (MDD 93/42/EEC, MDR)Fluent English, spoken and written, any other language an assetProven track record of accomplishments. Additionally, be familiar with good manufacturing practices, Six Sigma principles, and ISO requirementsA track record of success through appropriate technical skills, including product registration and definition of successful strategies for product registrationsTechnical knowledge of product design, manufacturing and life cycle management. Ideally, have a global perspective and an understanding of quality assurance practices and requirements for medical devicesProven business perspective in regards to product registration including understanding how regulatory contributes to the overall performance of the businessAbility to effectively negotiate and influence management, peers and regulatory agencies in order to strike the right balance between ensuring compliance with regulatory requirements and business needsGreat communicator accross the whole organization with a proven expertise in the design and implementation of quality processes in a world-class device manufacturing organizationHigh dedication to develop an organizational culture that promotes and sustains quality and regulatory affairs as an element of superior business performanceEnergetic, result-orientated professional with strong execution abilities and high customer focusBeing able to build up trustworthy and effective collaborations
We offer...Being part of a dynamic, inspired and engaged teamTake ownership as an expertCreate your footprint in the dental industry
Florian Rupp, is your first contact for further questions you might have. For this position, we are not asking for profiles of HR Consultancies and Recruiting Agents. Please respect this.
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