International Medical jobs in Tasmania
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- Sasmar PharmaceuticalsTasmania
- Monitoring and ensuring compliance across medical devices and food supplements.
- EU regulatory framework knowledge essential, broader international experience a…
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- HMJ EquityAustralia
- Health insurance
- Company phone
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- Sasmar PharmaceuticalsTasmania
- Preparing and submitting registration dossiers for new and existing markets.
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- MSS SecurityTasmania
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- MSS SecurityTasmania
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- Tasmania Football ClubHobart TAS 7000
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- BarmincoTasmania
- Relocation assistance
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Head of Regulatory Affairs & Quality
Job details
Pay information not provided
Full-time
Tasmania
Full job description
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
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