In this role you will be responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting.
Remuneration: £35,000 - £40,000
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.
The Senior Regulatory Officer is responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with an established quality management system, overseeing initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting
SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Senior Regulatory Compliance Officer to join their team on a permanent basis.
The Role
Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
The work of the Facilities team ensures that operational services can function efficiently in well-maintained environments, meeting legal and safety standards.
They pride themselves on offering expert advice and practical solutions to improve the facilities of the wider business across Scotland, helping operate their services to the highest standards.
As a leading business in Edinburgh, this company are committed to supporting a wide range of services across Scotland.
To operate pharmaceutical plant to manufacture bulk pharmaceuticals, intermediates and other chemical products in accordance with current good manufacturing practice (cGMP) and Health and safety practices.
Principal accountabilities
To recognise key reaction criteria and notify a Supervisor or Shift Manager of any unusual signs.
To perform chemical reactions according to batch sheet and process instructions as requested.
The Department for Business and Trade ("DBT") and Inspire People are partnering together to bring you an exciting opportunity for a Process Improvement Maturity Lead to create and deliver a Technical Services Improvement Plan which will sit at the heart of the DDaT programme of governance and assurance improvement across their technical estates.
Salary between £53,560 to £65,300 plus excellent Civil Service benefits including 28% pension contribution.