The OSA’s regulatory advice service – a key element of membership for many optical businesses – is moving to safe new hands as Ann Blackmore retires after six years at the helm.
Ann’s extensive knowledge of the optical landscape, both in the UK and Europe, comes from her positions within EUROM 1, the European Council of Optometry & Optics, plus time at FODO.
The role of OSA regulatory consultant is now moving to Mathias Semombwe, who brings over six years’ quality and regulatory experience gained through his work across the medical device, pharmaceutical, and healthcare sectors. Over the past three years, he has worked within the optical industry, most recently serving as QA and Regulatory Manager at Sparca/AOS, where he has been responsible for ensuring compliance with ISO 13485, ISO 27001, MDR 2017/745, and FDA CFR Part 11. The development and implementation of Quality Management Systems (QMS) and Information Security Management Systems (ISMS), liaising with Notified Bodies and EU representatives, and overseeing internal and external audits, are his forte.
Prior to this, Mathias held senior QA positions at Nelsons Pharmaceuticals and GlaxoSmithKline (GSK), where he developed extensive experience in Good Manufacturing Practice (GMP), risk management (FMEA), CAPA processes, and regulatory compliance.
Mathias is looking forward to delivering the quarterly reports for OSA members and answering direct questions from businesses – large and small – who have queries about any aspects of regulatory matters, both present and impending.