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.
- 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