3 days ago

Regulatory Affairs Officer


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Regulatory Affairs Officer

Qu otient is a commercial - stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™ , its next generation automation p latform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ ™ will be the first fully automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time - consuming manual testing. MosaiQ ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing , manufacturing and commercializing transfusion diagnostic products. The company's operations are based in Switzerland, Scotland and the US. We are now recruiting for our next: Regulatory Affairs Officer Quotient are recruiting for a Regulatory Affairs Officer to join the R egulatory Affairs Team based in Eysins. This role entails: ? Managing the product license registration with the appropriate regulatory authorities on a worldwide basis. ? Liaising with regulatory bodies to confirm compliance issues and to provide this information to the appropriate staff groups ? Planning, co - ordination, preparation and interpretation of relevant information necessary for product license applications and registrations. ? Ensuring successful granting, maintenance and development of all regulated products as required on a world wide basis. ? Compiling product information for the preparation of technical files and regulatory dossiers to support product license applications and product license maintenance for worldwide Regulatory Authorities. ? Ensuring that changes are documented in accordance with corporate quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities. ? Master degree or equivalent diploma in science with min. 5 years experience in a regulatory affairs department. ? The ideal candidate has significant specialist knowledge of regulatory affairs as applied to electrical medical device instrumentation, in vitro diagnostic medical devices, software validation and an understanding of the operation of a medical device manuf acturing establishment. ? Knowledge and practical experience of CE and FDA regulations, including the preparation of technical files required. ? Knowledge of 98/79/EC IVD directive, 2014/53/EU radio equipment directive, RoHS, WEEE preferred. ? Knowledge of elec trical medical devices industry standards as it applies to risk management, usability engineering, electrical safety, EMC, cybersecurity, ? Ability to prepare coherent regulatory reports and filings. ? Knowledge and or experience with US FDA submissions: PMA, BLA and/or 510k, preferred. ? Autonomous, Team Player, e ffective external communication with staff from regulatory bodies, customers, distributors and labelling and packaging suppliers. ? Excellent spoken and written English

Route de Crassier 13 Terre Bonne Park Bâtiment B 1 1262 Eysins