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 fast-moving international business

- EU regulatory framework knowledge essential, broader international experience a solid 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 quick we can grow
- A product that genuinely helps people

📌 Head of Regulatory Affairs & Quality (Tasmania)
🏢 Sasmar Pharmaceuticals
📍 Tasmania