Head of Regulatory Affairs & Quality
SASMAR· Regulatory
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
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.
- 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
Frequently Asked Questions
Is the salary disclosed for the Head of Regulatory Affairs & Quality position at SASMAR?
The salary for this Head of Regulatory Affairs & Quality role at SASMAR is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Head of Regulatory Affairs & Quality position at SASMAR located?
This Head of Regulatory Affairs & Quality role at SASMAR is based in Ta' Xbiex, Eastern Region, Malta. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Head of Regulatory Affairs & Quality role at SASMAR full-time or part-time?
This is listed as a Full time position. It is posted as a Head of Regulatory Affairs & Quality role in the Regulatory department at SASMAR.
Which team or department does the Head of Regulatory Affairs & Quality at SASMAR belong to?
This Head of Regulatory Affairs & Quality position is part of the Regulatory department at SASMAR. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Head of Regulatory Affairs & Quality position at SASMAR?
Click the "Apply Now" button on this page. You will be redirected to SASMAR's official application portal hosted on workable where you can submit your application directly.
When was the Head of Regulatory Affairs & Quality job at SASMAR posted?
This Head of Regulatory Affairs & Quality position at SASMAR was posted on Sep 30, 2026. Apply as soon as possible — early applications are often reviewed first.
Head of Regulatory Affairs & Quality
SASMAR
You'll be redirected to SASMAR's official application page on workable.