Working within our clients Quality Assurance and Regulatory Affairs function, this role will involve applying immediate knowledge and understanding of the regulatory and legal frameworks, particularly working with the MHRA and HPRA.
The role will include, but not limited to, the following:
* Manage and direct writing and review of regulatory processes and procedures to ensure compliance, efficiency and clarity;
* Prepare quality regulatory applications (such as product registrations with the MHRA) and regulatory responses for UK and Ireland;
* Manage the life-cycle maintenance of existing MAs;
* Preparation, maintenance and quality check of Product Information e.g. SmPC, PIL, labelling, artwork.
* Working with cross-functional groups to ensure the development of regulatory strategies for the CE marking of new Medical Devices in accordance with the business goals;
* Local GDP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and subsequent process improvement initiatives;
* Raising CAPAs and deviations as necessary and following up until closure.
Full job description available on application
* Candidates should have 3-5 years of experience preferably in Regulatory Affairs, Quality Assurance; Good knowledge of CE marking of medical devices; Knowledge and awareness of the relevant regulatory guidelines and legislation;
* Highly experienced in filing national variations with MHRA, ideally with an interest or experience in eCTD, publishing and use of electronic portals
* Only candidates with existing right to work in the UK/EU will be considered
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