elemed
Regulatory Affairs Specialist
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🔎 Title: Regulatory Packaging and Labelling Compliance Consultant (Contract)
📍 Location: Remote. UK or wider Europe considered.
📅 Contract: 4-6 months, starting early September
✉️ Contact: ahmed@elemed.eu
The EU's new packaging rules came into force in August, and a lot of medical device companies are now working out what that means for every product they sell. This is one of them, and they want someone to do the work rather than write a report about it.
🔸 The opportunity
Our client is a global manufacturer and distributor of medical devices products, with a very large portfolio sold across Europe and beyond. They are catching up on packaging and labelling requirements at speed, with customers already asking questions they can't yet answer.
You'll work alongside their packaging engineer to build the system that lets them answer those questions. Some products carry six layers of packaging, each with its own supplier and its own compliance evidence, and none of it currently sits in one place. Your job is to map all of it, work out what evidence is missing, get it out of the suppliers, and leave behind a database the internal team can maintain once you've gone.
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This is a hands-on build. You'll be chasing suppliers, reading specifications and creating records, not advising from a distance.
🔸 What you will be responsible for
- Mapping packaging layers and materials across a large product portfolio
- Working out which suppliers need to provide what evidence, and requesting it
- Collecting supplier declarations and certifications, including PFAS and heavy metals
- Building and populating a supplier and packaging compliance database
- Working with the packaging engineer and the wider quality team to close gaps
- Supporting declarations of conformity and the documentation behind them
- Flagging where packaging or labelling will need to change, and what that affects
- Setting the records up so the internal team can keep them current after the contract ends
🔸 You could be a strong fit if you have
- Experience in packaging or labelling compliance in a regulated product environment (medical devices, pharmaceuticals, cosmetics, food or consumer goods)
- Working knowledge of EU packaging or product compliance requirements, ideally including PPWR, restricted substances or extended producer responsibility
- A track record of getting compliance evidence out of suppliers, including the ones who don't reply
- Strong documentation and data discipline, and confidence building structured records from a standing start
- The ability to work independently with an international team
- A general understanding of how products are packaged. A packaging engineering background is welcome but not required
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Useful but not essential: PPWR, EU Deforestation Free Regulation (EUDR), EU MDR labelling experience, ISO 13485 exposure, or a previous supplier compliance data collection project.
Both full-time and 3 days a week are workable, so if you're an experienced specialist with limited availability, it's still worth a conversation.
Interested in learning more? Send me a confidential message or contact ahmed@elemed.eu
About Elemed
Elemed is a specialist consultancy and talent management agency focused exclusively on the MedTech, Digital Health, Diagnostics and Pharma industries. We help healthcare companies bring products to market faster by combining technical consulting, strategic hiring and professional development. Want career inspiration? Listen to our executive podcast here.
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