Description

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 quick-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.

Advantages
Market-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

📌 Head Of Regulatory Affairs & Quality Tasmania
🏢 Sasmar Pharmaceuticals
📍 Tasmania