Duration: 3-6 months plus (then hope to convert permanent as Sr. RA Resource)
A Black Diamond client is looking for a Senior Regulatory Affairs Consultant. This person will be working in the Regulatory Affairs Group writing NDA and ANDA applications and helping with the ECTD submissions. This person should be very strong in Design Controls and Design History Files as the products are combination products. This will be an individual Contributor Role but there could be some mentorship involved as well.
- Most Important Skills Needed: Regulatory Affairs, Authoring NDA and ANDA Applications, Design Controls, Combo Product/Medical Device
- 5-10 years of Medical Device experience is a MUST for this position and Combination Product Experience is a MUST.
- The products are Auto injectors and pre-filled Syringes, is a plus if they have experience with these specific products.
- Education Requirements: B.S. Degree Required (Preferably in a science)
JOB ID# 227153