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Regulatory Affairs Officer

Posted Date: 25-Jul-2021

Location: Eysins, VD, CH, 1262

Company: Quotient

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage
diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.

 

REGULATORY AFFAIRS OFFICER

 

Quotient is recruiting for a Regulatory Affairs Officer to join the Pre-Market Regulatory Affairs Department based in Eysins. The role is a full-time and permanent position.

 

The Regulatory Affairs Officer 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.

 

JOB DESCRIPTION

The main responsibilities will include:

 

  • Prepare, write and compile regulatory documentation, coordinate and execute regulatory submission with FDA, European Notified Bodies, Health Canada and any other territories as appropriate;
  • Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met;
  • Advise Quotient staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) – Part 1  and other non-registered product requirements to support compliance for Quotient and its products;
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information;
  • Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.
  • Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities;
  • Assist with the implementation of the Company’s Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards the 98/79/EC IVD Directive, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • A relevant degree and/or relevant work experience in a regulatory affairs environment;
  • Ability to prepare coherent regulatory reports and filings;
  • Sound knowledge and expertise with core IT packages i.e. MS Office;
  • Clear spoken and written communication;
  • Effective external communication with staff from regulatory bodies, customers, distributors and labelling and packaging suppliers;
  • Proactive and able to work effectively independently or within a team, participating in R&D project teams as required and deliver end results under tight timelines;
  • Great attention to detail with a thorough and methodical approach to work.
  • Ability to analyse information in a structured manner;
  • Ability to work under pressure of a high workload, meet deadlines and respond flexibly;
  • Effective time management and prioritisation skills;
  • High sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the same;
  • Good business acumen;
  • Fluent in English.