Meet the Advena Team
Advena is comprised of three business units, encompassing our broad spectrum of expertise, Pan-European operations and global client base. The team includes highly experienced practitioners with over 30 years experience in regulatory affairs.
30 years experience in global medical device regulatory affairs including the position of Vice President of International Regulatory Affairs with the US multi-national Sherwood Medical.
20 years experience in Quality Management, Medical Device Regulatory Affairs, Microbiology, Clean Room and Sterilisation Validation.
20 years of experience in Business Management, Systems & Procedures, 10 years of experience in the Medical Industry and 4 years as Management Representative for Quality Management Systems.
Over 5 years’ experience in Quality Management and Medical Device Regulatory Affairs including EU submissions. Qualified Analytical Chemist with 12 years R&D Pharmaceutical experience.
A Medical Device consultant with extensive experience of both regulatory and quality projects in accordance with both European and United States standards. Previous experience with Neurological, Orthopaedic, Contraceptive Device and Procedure Pack devices, compiling both CE Technical Files, Design Dossiers and 510 (k) submissions (k) for US market as well as submissions for Australia, New Zealand, Canada and Japan.
Four years’ experience as Medical Device Regulatory Administrator involved in TF submission and specialising in Biocompatibility, Sterilisation and PMS. Qualified Medicinal Chemist with 17 years’ experience working in Chemistry and Molecular Biology research in the University sector.
A medical device regulatory consultant with a biomedical and mechanical engineering background experienced in the creation and review of technical documentation and QMS, as well as in handling vigilance issues and PMS for a vast array of medical device types and classifications.
Over 3 years’ experience in Quality Management and Medical Device Regulatory Affairs including Technical Files, Non-EU medical device registrations and internal auditing to ISO 13485: 2016. Trained in Cosmetics regulations in accordance with EU 1223/2009 and construction of Product Information Files.
A medical device consultant with extensive knowledge of the medical device regulatory field with a PhD, a MSc and a BEng in Biomedical Engineering. Also experienced in compiling and reviewing technical documentation for a variety of medical devices and IVDs in compliance with MDR/IVDR.
Over 6 years experienced in Business Administration, Customer Service, Account Management and sales.
Grishma joins Advena on an intern placement as part of her Master’s Degree at Aston University – MEng Biomedical Engineering, providing regulatory support to our team of consultants.