A Black Diamond client is seeking a Labeling Specialist with strong ISO 13485 and IVDR experience. We are looking for consultants to standardize our client’s labeling process. They would like this person to collect the label requirements and create 1 document to find a single source of truth for each product, such as where the expiration date, shelf life, and geographic info come from. This is not a remediation role, just looking to create a single source of documents for all products. Our client needs to figure out what they need in their product label for NPD and NPI, agree on who provides content and where to put it, and what the template is for all new releases. Ideal candidates need CFR part 801 (or FDA labeling experience) 13485 experience as well. Our client has a good idea of reagents and what to do there but needs to find somebody with the expertise for the instruments, and IVD experience is very beneficial.
- Medical Device Labeling
- Creating labeling content
- ISO 132485
- CFR 21 part 801
Remote: Med Device Labeling Consultant (228207)