Senior Regulatory Specialist
hace 1 semana
col-wideJob Description:Solenis, is a global manufacturer of cleaning and hygiene solutions, pool products and Paper&Pulp solutions for the industrial and professional market. Many chemical products, especially disinfectants an medical device products, marketed in the European economic area need to be compliant, safe and effective according to companies policies and EU member state regulations and EU wide applicable regulations like the REACH Regulation, Biocidal Products Regulation (BPR), Cosmetic Products Regulation, Detergents Regulation, General Food Law Regulation and Medical Device Regulation (MDR).The Senior Regulatory Specialist Registration will provide regulatory expertise and advice on our product portfolio that require a registration e.g. disinfectant, products and medical device products. He or she will lead authorization projects like Union authorization process on EU level, pre-BPR registration projects that will require European roll-out or European ecolabel processes. In addition he or she will participate in the registration projects to obtain medical device registrations in and across Europe.MAIN RESPONSIBILITIESPrepare and organise the registrations of Diversey, Innovative Water or Solenis products positioned as disinfectants, pool and other biocidal products by preparing (master) registration files in collaboration with internal product development to ensure successful authorizations in the end;For our Medical device registrations takes care of the regulatory aspects of the technical dossiers and ensures good alignment with other aspects of the technical dossier, representing regulatory in audits of the notifying bodies, and participates in Diversey quality system for Medical Devices (including production). And in close cooperation with the local regulatory colleagues – takes care of the country compliance activities for these medical devices (Class I and II).Submit and follow up on submitted European dossiers. In case of questions or challenges, finds acceptable solutions for Diversey as well as the European member states evaluation these dossiers;Coordinates the (master) file registration process roll out, executed by Diversey local regulatory compliance personnel, our Global Service center and, if relevant, other partners taking care of country submissions activities;Maintains in-depth knowledge of relevant regulations and guidance, monitors new regulatory developments, identifies potential impact on the product portfolio;Partners with R&D and marketing to give input into successful innovation designs and product implementations;Help to manage the Diversey's global biocides portfolio and ensures alignment with biocides, medical device and product strategy according to annual and strategic plans of Diversey;Gives internal and external presentations, including representing Diversey at competent authority and industry meetings as required.REQUIREMENTSMaster/PhD degree in Chemistry, Toxicology, Chemical Engineering, Biology or related fields;Working experience of 3-5 years in contacting competent authorities and/or notifying bodies (product registration, risk assessments, regulatory consulting or equivalent);Working knowledge of product registration, compliance requirements and contact with competent authorities is required. Additionally experiences with disinfectants, EU Ecolabel, Nordic Swan, food contact, detergents, food safety or cosmetic registration and compliance requirements are a pre;Experience in an international business environment;Good negotiation, presentation, and analytical skills;Fluent in English, both written and spoken. Other European languages are a pre;Possesses knowledge of regulatory terminology and regulatory landscape;Demonstrated success in completion of difficult tasks in a timely manner, showing bias for action and drive for results;Devises insightful ways to understand and solve difficult problems, whose solutions require the use of multiple techniques and some understanding of the materials;Willing to (limited) travel in Europe facilitate contact with authorities, government agencies and industry groups or with Diversey colleagues.WHAT CAN YOU EXPECT FROM SOLENIS?We ask a lot of you, so there should be something in return. You can count on an environment where you can grow as a professional, not only in your role, but also as a person.We take good care of each other and look at how you can work best.In addition to a good salary, you will receive an end-of-year bonus and a good bonus scheme.Solenis has a very good pension scheme, where you only pay a small personal contribution.On top of that, you will get a group of great colleagues (even though we say so ourselves) and most importantly, you have a lot of autonomy and you can use your knowledge and experience to really make an impact.Would you like to apply?Do you have what it takes to further develop and help Solenis grow? Then we look forward to receiving your CV.Job Type: Full-timeWork Location: In person#J-18808-Ljbffr
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