Regulatory Compliance & Post-Market Surveillance Officer

• 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. We are now recruiting for our next Regulatory Compliance & Post-Market Surveillance Officer.

Job Description

Quotient is recruiting for a Regulatory Compliance & Post-Market Surveillance Officer to join the Regulatory Affairs Team based in Eysins. This role entails:

• Establish, implement and maintain the post-market surveillance process


• Lead and coordinate the vigilance process in interface with the complaint handling process


• Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (Biological Products Deviation Reports)


• Be the main point of contact for regulatory compliance issues


• Evaluate changes for compliance to regulatory requirements and ensure changes are communicated in a timely basis as appropriate to the Regulatory Authorities (change control)


• Evaluate Product/Processes Non-Conformances, determine their impact on regulatory submissions, determine whether they need to be reported to the Competent Authorities


• Establish, implement and maintain regulatory processes, such as industry regulatory and standards watch and their implementation within the Quality Management System


• Contribute to the IFU process, ensuring tools are available to ensure regulatory requirements are known and met

Qualifications

• Master degree or equivalent in life sciences and 3 years of experience in a regulatory affairs or quality assurance role


•  Experience in medical device, IVD or biotech industry


• Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc.)


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


• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization


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


• Effective time management and prioritisation skills


• Excellent spoken and written English