Berufsbezeichnung: Senior Regulatory Affairs Officer

Arbeitsbeschreibung:
Quotient in Eysins is looking for a Senior Regulatory Affairs Officer 100% Quotient 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 platform 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 uour next: Senior Regulatory Affairs Officer Job abstractJV_description : The role is responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide. His/her main activities will be: - Prepare, coordinate and execute regulatory submission with: FDA, European Notified Bodies, Health Canada and any other territories as appropriate - Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation - Review analytical data from development studies, performance evaluation studies, and clinical field trials to ensure regulatory requirements are met - Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information - Advise Quotient staff and project team members on data and information required for successful license applications and co-ordinate their efforts - Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications worldwide - Contribute to the design and implementation of regulatory processes and identify areas for potential improvement - Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance and industry standards - Providing support, guidance and training as needed to fellow team members to ensure maintenance of world class regulatory team - Assist with the implementation of the Company’s Quality Policy Qualifications & Experience required : - Scientific degree (Master level) with a minimum of 5 years of experience in regulatory within the Lifescience Industry (Medical Devices, IVDs, Drugs or Biologics) - Previous experience in bringing a new product to market, significant experience of Design Control or Development project - Previous filing experience in EU and USA: BLA, PMA, 510(k), high class CE marking submission - Significant specialist knowledge of regulation as it applies to Medical Devices, IVDs, Drugs or Biologics as well as related industry standards - Ability to interface with regulatory authority - Good technical writing skills and ability to negotiate/convince - Must be a team player and a very good communicator - Effective time management and prioritisation skills - Eagerness to work in a fast-paced, rapidly evolving environment requiring high flexibility - English fluent Apply : https://www.smartrecruiters.com/QuotientLimited/743999674875342-senior-regulatory-affairs-officer

Angestelltenname: Quotient Suisse SA