Plymouth, England, United Kingdom
Experienced Regulatory Affairs Manager working with medical devices
Provided specific support for the development of new products, product registrations and lifecycle management for EU and US territories from 2021 to 2025 and support for all aspects of Regulatory Affairs from 2025 onwards • Responsible for a range of devices from different manufacturing sites and notified bodies • Management of a team of staff based locally and remote (UK and international) • Preparation and maintenance of departmental budget • Member of site operational management team • US 510(k) clearance (K211878) of a topical wound closure device • EU MDR approval of topical wound closure device and implantable hernia mesh fixation device • Subject matter expert for department during audits • Supported milestone assessments and review of submission strategy for new company acquisitions Product scope covered • Topical and implantable cyanoacrylate based devices: EU (Class I, IIa, IIb, III), US (Class 1, 2, 3) • Implantable alginate based devices: EU Class III
Provided support on all aspects of Regulatory Affairs from 2017 to 2019 and specific support for the development of new products, product registrations and lifecycle management for EU and US territories from 2019 to 2021 • US 510(k) clearance (K183570) of a topical wound closure device • US launch of 2 new topical wound closure devices and a skin protectant device • EU launch of 3 new topical wound closure devices • Supported product recall in EU and a range of international territories • Supported Notified Body and FDA audits Product scope covered •Topical and implantable cyanoacrylate based devices: EU (Class I, IIa, IIb), US (Class 1, 2)
Provided support on all aspects of Regulatory Affairs • US 510(k) clearance (K151182) of a topical wound closure device • US launch of a new topical wound closure device • International registrations of products to support business growth • Vigilance and postmarket surveillance reports Product scope covered • Topical and implantable cyanoacrylate based devices: EU (Class I, IIa, IIb), US (Class 1, 2)
Worked on custom-made devices and international registrations for a range of implantable vascular grafts, endovascular stent grafts, porcine heart valves.
Supported compilation of CTD for a consultancy contracted to work on a range of medicinal products.
Performed research into a range of inorganic materials involving the use of solid-state NMR and DFT calculations.
Worked in the synthetic support (scale-up) lab producing larger batches of key intermediates and candidate drug molecules.