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.
A friendly professional approach is part of the Advena ethos, so if you have any questions or queries please contact us, we’d be delighted to discuss your requirements.
Managing Director – Advena Ltd (UK & Malta)
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.
Managing Director – Advena Medical Ltd
20 years experience in Quality Management, Medical Device Regulatory Affairs, Microbiology, Clean Room and Sterilisation Validation.
Director of Business Services (UK & Malta)
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.
Senior Regulatory Consultant
A broad wealth of knowledge and experience in medical device regulatory having previously worked in a number of senior regulatory roles and with many devices including IVDs, combination products, cardiovascular and wound-care devices, across all stages of the device life-cycle such as supporting the development, initiation and running of clinical investigations, obtaining regulatory approvals and controlling PMS and vigilance activities.
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 10 years’ in the medical device industry with experience in clinical investigations, IVD research, quality management systems, regulatory submissions and risk management. Ex notified body quality management systems auditor experienced in ISO 13485: 2016 and MDSAP audits.University sector.
Senior Regulatory Consultant
10 years’ in the medical device industry with experience in clinical investigations, IVD research, quality management systems, regulatory submissions and risk management. Ex notified body quality management systems auditor experienced in ISO 13485: 2016 and MDSAP audits.
Bachelor’s degree in mechanical engineering and a Master’s degree in biomedical engineering specialising in medical physics with a
keen interest in medical device design and regulation.
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.
Contact the Advena team to discuss your requirements:
Telephone: +44 (0) 1926 800 153