Head of Regulatory Affairs & Quality

About this role

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
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• **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