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.
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.
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 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
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.
Belcan Workforce Solutions is excited to offer a contract opportunity for a Senior Instrumentation & Controls Engineer at the Fife site of a multinational oil and gas corporation.
This position is for a 12-month contract, offering full-time on-site work within an IR35 framework.
Tasks & Responsibilities
Evaluate / comment work performed by the Contractor and sub-contractors.
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