Below are the high level requirements for the contractor position for a 4-5 months project in Design History file remediation:

1. Engineering degree in any discipline. Mechanical, biomedical preferred.
2. Experience in Creating, managing, and remediating Design History file (DHF) in accordance with 21 CFR part 820 for drug-device combination products
3. Experience in creating, managing, and remediating risk management file (RMF) in accordance with ISO 14971:2019 for drug-device combination products
4. Capable of quickly learning and implementing departmental procedures for DHF and RMF in a fast paced work environment.
5. Good understanding of development and manufacturing of Transdermal delivery systems (TDS).