Aug 09, 2021

Senior RA/QA Consultant

  • Compliance Solutions (Lifesciences) Ltd
  • Remote (United Kingdom)
Full time Consultant Quality Regulatory

Job Description

Compliance Solutions is looking for a Senior Quality/Regulatory Consultant to help support all activities within the organisation. The role is homebased in the UK, with travel to clients sites when required.

Key areas of responsibility: 

  • Set up/Maintenance of technical documentation & design dossiers
  • Undertaking US FDA 510(k)s, PMAs (Premarket Approvals), IDEs (Investigational Device Exemptions), Pre-Submissions and Designations Submission
  • Regulatory submissions – global markets
  • Support for the development of the company's regulatory planning, incorporating strategies for the product range in accordance with global requirements.
  • Administrate regulatory dossiers to support product license applications, import license and product license maintenance for Regulatory Authorities
  • Quality Management Support
  • Solving regulatory questions on classification, technical files, device master records (DMRs). Device history records (DHRs). Design history files (DHFs), process validation, software validation
  • Conduct or advise on design / product risk management activities
  • Reviewing, updating and writing of Clinical Evaluation Reports (CER’s)
  • Conduct or advise on post market surveillance and vigilance
  • Support to maintain or expand market access to various markets including EU, USA, UKCA
  • Conduct or advice on validation projects
  • Management of quality systems
  • Compliance with the European Medical Device Regulation (MDR)/ Invitro Diagnostic Regulation (IVDR)
  • Support product risk management activities and the life-cycle of marketed products.
  • Support for the post-market surveillance, preparing reports for the product range.
  • Support the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post-market activities.

Qualifications & Experience:

  • Degree qualified preferably in a life science and experience working within a regulatory affairs arena.
  • Knowledge of ISO 13485, FDA 21 CFR 820 and CE/FDA submissions
  • Excellent organizational skills and an ability to work to tight timelines.
  • Demonstrate strong team skills.
  • Proficient in the use of IT, including Microsoft Office suite and Electronic Document Management systems.
  • Excellent communication skills when liaising within the company and with external customers.

Attributes: 

  • You like to roll up your sleeves and get stuff done!
  • Curious and passionate about innovative health technology
  • Ability to plan and manage own workload; flexibility to deal with peaks and troughs
  • Ability to work on own initiative in remote working environment,
  • An ability to harness strong working relationships with clients

Apply Now