# Head of Regulatory Affairs & Quality

**Company:** [SASMAR](https://jobs.workable.com/companies/qHS5ErKADH1Nh8xorz6uvZ.md)
**Location:** Ta' Xbiex, Malta
**Workplace:** on site
**Employment type:** Full-time
**Department:** Regulatory

[Apply for this job](https://jobs.workable.com/view/bf5f191c-4db8-445a-8a53-3609b1781330)

## 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 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