Our client is a global medical technology company with sites across the UK and US. They focus on developing and manufacturing diagnostic care solutions and also take these products to market and commercialisation. They are currently experiencing growth and expanding their business so will be recruiting proactive and enthusiastic people to support the growth of the business, one of the roles they are recruiting for initially is a Regulatory Affairs Manager.
You will be responsible for all regulatory activities for the manufactured products associated with medical devices (assays, instruments, software and ancillary items), development through the R&D phase and the verification and validation phase through launch and post marketing. You will be responsible for activities such as generation documentation/process creation and approval of documents.
- You will be responsible for Management or regulatory dossiers of all legal manufactured products for pre and post market
- Management and Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier.
- Creation and maintenance of harmonized standards compliance plans
- Creation and maintenance of regulatory procedures to align with Global requirements
- QMS updates required for higher risk IVD’s such as PMA and WHO pre-qualification programme activities.
- Review and approval of change requests for regulatory impact assessment
- Management of regulatory process relating to marketing collaterals and country localization process
- Review and approval of Labelling and marketing collaterals
- Lead and manage a team of Regulatory Specialists working in pre and post market environment, including day to day activities to support the business in accordance with pipeline plans and non-routine activities as required by the business.
- Support the training and development needs of the team
- Provide training for other areas of the business on regulatory process and other compliance activities.
- You will be highly motivated with a 'can do' attitude
- You will have the ability to ensure positive and proactive relationships with both internal and external stakeholders
- You will take ownership and have a high level of personal accountability and have the ability to plan and organise work effectively
- You will have a degree in a relevant scientific discipline
- Demonstrates the ability to solve problems under conditions of uncertainty and ambiguity and is able to think strategically in times of pressure to drive toward the best solutions
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EC/IVDR
- Development and writing of CE marking technical files
- Detailed knowledge of post market regulatory activites including FSCA
- Experience and knowledge of vertical and horizontal standards for IVD Medical Device instruments, software and assays in the point of care.
This is an excellent opportunity to join a very success and expanding company with global exposure