Posted by Service Care Solutions - Legal • £186.62/day to £187.62/day
This role will work as part of the Inquiry legal team to flexibly and constructively ensure the efficient delivery of outcomes.
The ideal candidate will have a flexible and adaptable approach to work.
This is a unique opportunity to support from the outset, a high-profile statutory Public Inquiry investigating Scotland's response to the COVID-19 pandemic.
This role offers full or part-time working, flexible and hybrid hours.
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Loriens leading public sector client is looking to bring on a Compliance and Assurance Manager on an initial 6-month contract.
Responsibilities
Collate, ready for presentation all of the necessary collateral needed for preparing the Gateway assessments within the team.
Facilitate the preparation and maintenance of the collateral for the Authority to Proceed Packs (ATPs) for each work stream as they move through the Framework.
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.