Compliance Solutions (Lifesciences) Ltd

Compliance Solutions (Life Sciences) Ltd. (“Compliance Solutions”) has many years of experience within the life science industry (including blood establishments) advising on how to best meet the regulatory requirements of the MHRA, FDA, Notified Bodies and ICH, for the one man start up to multi-national companies.

Compliance Solutions supports its clients by providing a risk-analysis based approach to meeting their quality and regulatory needs.  We provide our clients with clear, hands on, cost-effective guidance to assist with the development, approval, manufacture, storage and distribution of their products.

Our consultancy services range from design, implementation and maintenance of quality management systems, preparation of technical files for regulatory approvals, part-time and interim management support, auditing both internal and external, management reviews and presentations, training and mentoring.

Compliance Solutions understand that your business will often have a varying requirement for consultancy support to meet the fluctuating needs of particular projects and activities.  That is why we provide you with a flexible approach that is tailored to your requirements.

Aug 09, 2021
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...
Compliance Solutions (Lifesciences) Ltd Remote (United Kingdom) Full time