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Open nowPosted 4 days ago

Head of Regulatory Affairs & Quality

Workable (global search)107,990 open roles

Where
Ta' Xbiex, Eastern Region, Malta
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Your applicationOpen nowHead of Regulatory Affairs & QualityWorkable (global search) · Ta' Xbiex, Eastern Region, Malta

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Early applications get read.

7.9% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 6 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 7.9%7 days
  4. 14.9%14 days
  5. 34.0%30 days
This job: posted 4 days ago

Workable (global search) median: 6 days open

The posting

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
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