Quality and Regulatory Affairs Specialist in Bucuresti

Job SummaryFounded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.Currently we are looking for a person, who can join our team  as a Quality and Regulatory Affairs Specialist.On this position you are going to be  responsible for the product registration in different markets in accordance with the local legal requirements. You also need to be the main contact between the organization and authorities to ensure reliable forward of information.Principal Duties and ResponsibilitiesSupport implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/proceduresManage customer complaints handling and instructed actions e.g. product blockings, recalls, provide field safety notices, etc. Product enquiries on own responsibility via SAP system are essential requiredResponsibility for product registration on the market in accordance with local legal requirements; main contact for the local competent authority and responsibility for the maintenance of the business in the local marketSupport the internal and external audits; also within an internal auditor team coordinated by headquarters (if applicable)Continuous communication with QA/RA EMEASupport other Zimmer Biomet distribution organizations with regards to QA/RA requirements (e.g. product registrations/renewals, etc.)Involvement in special projects and special duties, like (re-)validation of technical systems and proceduresEducation/Experience RequirementsS. degree in engineering, business, political science or equivalent experience3 to 5 years’ experience in registration activities and/or quality assuranceExperiences with regards to international medical device regulationsKnowledge of ISO 9001, ISO 13485 and Medical Device Directive is a plusKnowledge of national medical device regulationsExperience with Windows Office Software, SAP eligibleEnglish language is a basic requirementTravel Requirements5%