Head of Regulatory Affairs & Quality

Conceive Plus and SASMAR are a global brand with products in 70+ markets. As we scale, regulatory and quality can't be an afterthought - it's what keeps us moving fast without breaking things. We need someone who owns it. What you'll be doing Leading regulatory affairs across all markets - product registrations, renewals, dossier management and submissions Owning and maintaining ISO 13485 certification and our Quality Management System Monitoring and ensuring compliance across medical devices and food supplements Reviewing and approving product labelling, claims and packaging for all markets Supporting new product development from a regulatory and compliance perspective - in early, not at the end Staying ahead of regulatory changes across key markets and flagging risk before it becomes a problem Working closely with supply, marketing and product teams to keep launches on track Requirements What we're looking for Solid experience in regulatory affairs and quality within medical devices, food supplements or OTC ISO 13485 knowledge is essential Experience managing country registrations across multiple markets Detail-oriented but commercially aware - knows how to say yes safely, not just no Proactive, organised and comfortable working across a fast-moving international business EU regulatory framework knowledge essential, broader international experience a strong plus Medical Device Responsible Person Fluent in English, with full rights to live/work in Malta **No work permits are offered for this role, you must be authorised to work in Europe. Benefits Competitive salary + performance bonus Based at our Malta headquarters with an international team Real ownership of a function that directly shapes how fast we can grow A product that genuinely helps people