Experience: Min. 2-5 Years
CTC: As per industry standards.
Key Responsibilities:
- Assist in compilation of technical documents to support country specific regulatory submissions in a format consistent with applicable guidance documents.
- Providing support to Manager QA/RA in compiling QMS and Technical Documentation.
- Stay informed of regulatory procedures.
- Other duties as assigned
Requisite Skills:
- Experience with medical devices vascular implants / accessories will be added advantage.
- Knowledge of EUMDR, Stability studies, Drug pharmacology, Kinetics, Release
- Regulations pertaining to DCGI.
- Excellent written and verbal communication skills
- Strong computer skills with experience in Word, PowerPoint, Excel, Outlook, Microsoft Teams.
- Graduate from Pharma / Science background will be preferred.