We are looking for an experienced EU/Germany regulatory & compliance specialist to help us obtain all required certifications / notifications / verifications / permissions needed to sell:
1) Vitamins (dietary supplements), and
2) Medical devices / medical equipment
in Germany and on Amazon.de.
We need a hands-on specialist who can audit products + documentation, identify gaps, and lead the compliance process (including coordination with labs, Notified Bodies, Authorized Representatives, etc., where applicable).
Scope of work:
1) Product classification and compliance strategy (vitamins/dietary supplements vs medical device vs other).
2) Germany + Amazon.de compliance roadmap per product/SKU.
3) For vitamins (dietary supplements): German label review, ingredients/dosages compliance, allowed claims guidance, BVL notification support, and a documentation package suitable for Amazon.de requests (labels, GMP, CoA, etc.).
4) For medical devices: MDR pathway (if applicable), CE requirements, technical file checklist, risk management/clinical evaluation guidance, UDI/EUDAMED direction (if relevant), importer/responsible operator requirements.
5) Prepare clear checklists, templates, and step-by-step actions; support execution until completion.