Product Compliance Manager Limited Duration until October 2018
Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops manufactures and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. As The Dental Solutions CompanyTM Dentsply Sirona's products provide innovative high-quality and effective solutions to advance patient care and deliver better safer and faster dentistry. Dentsply Sirona's global headquarters is located in York Pennsylvania and the international headquarters is based in Salzburg Austria. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. This position will be located in Ballaigues Switzerland.
Do you want to make an impact through your expert contribution ensuring compliance to international quality regulatory requirements Is your global view complemented by your ability to dive into detail where necessary As member of the Product Compliance group you will be responsible for managing quality and compliance aspects related to new product development product changes and product sustaining activities of the instruments platform. MAIN RESPONSIBILITIES Support R D for product change orders and new product developments for the instruments platform and for the associated products from the equipment platform from feasibility up to commercialization and along the product lifecycle Ensure compliance of product development projects to internal procedures and design control requirements Elaborate maintain technical files DHFs ERCs Provide expertise to R D for all applicable standards regulations specific to each project Lead risk activities during product development according to the applicable procedures and requirements e.g. ISO 14971 establish/maintain the Risk Management File Review design documentation along the development process design inputs V V design outputs marketing claims risk management labelling requirements Support the Regulatory Affairs Specialists for worldwide product registrations and in identifying product classification and regulatory pathways for certifications FDA CE INMETRO etc. Ensure the maintenance in conformity of the SBU Strategic Business Unit quality system and compliance of product development processes and application of new requirements Support SBU corporate and regulatory bodies' audits inspections Ensure Regulatory and Standards surveillance assess preliminary impact on the Endodontics product portfolio and regularly report to Business Unit Management PROFILE M.S. in mechanical materials or biomedical engineering Min. 5 years' experience in quality aspects related to product development with R D in medical devices and/or diagnostics Solid experience within international multi-disciplinary R D organizations in the area of medical device design control and regulations 21 CFR part 820 93/42/EC Directive quality management standards ISO 13485 and risk management ISO 14971 Knowledge of international standards requirements according to ISO 62366 14457 10993-1 17664 Excellent skills written and spoken in English C1 min. and French C1 min. Ability to build productive relationships in a dynamic international environment team-oriented autonomous result-oriented conscientious and thorough in execution
Ch. du Verger 3 1338 Ballaigues