Regulatory Project Manager

• Eysins, Switzerland


• Full-time

Company Description

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.

Job Description

Quotient is recruiting for a Regulatory Project Manager to join the Regulatory Affairs Team based in Eysins.

This role entails:

• Lead and coordinate project to implement new or updated regulation within the organization, including the new IVDR.


• Lead and coordinate regulatory processes projects.


• Be the point of contact with our UK based operations for standardizing regulatory practices.


• Support regulatory submission with International regulatory authorities.


• Advise Quotient staff and project team members on data and information required for successful license applications and co-ordinate work to ensure appropriate standards for submission.


• Compile product information for the preparation of technical files and regulatory dossiers to support product license applications worldwide.


• Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.


• Provide regulatory support, guidance and training as needed to fellow team members.


• Lead the design and implementation of regulatory processes and identify areas for potential improvement.


• Lead and coordinate the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance and industry standards.

Qualifications

• Master degree or equivalent in life sciences and 5 years of experience in a Regulatory Affairs within the life science industry (medical device, IVD or drugs or biologics)


• Prior experience in Project Management


• Previous experience filing high class CE marking submission and/or other countries regulatory submission


• Ability to interface with regulatory authority, analyse technical information and collect and interpret regulations, standards and guidance


• Demonstrated ability to negotiate and convince


• Ability to work in an international team in a fast-paced changing environment


• Effective time management and prioritisation skills


• Great attention to detail with a thorough and methodological approach to work


• Excellent spoken and written English

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