Recruitment Drive for Regulatory Affairs at Axio Biosolutions

Axio is a deep-science medical technology company with extensive expertise in biomaterials based medical devices for pre-hospital, intra-operative and post-operative clinical needs. Our focus is on devices for management of trauma, surgical and chronic wounds. We bring together our biomaterials expertise with the contemporary knowledge of medicine and engineering to design novel solutions for management of trauma, surgical and chronic-infectious wounds.

VIRTUAL RECRUITMENT DRIVE (REGULATORY AFFAIRS)

SENIOR EXECUTIVE (AHMEDABAD)
Experience : 3-5 years
Skills : Design History File (DHF), Risk Management, Post Market Surveillance (PMS), Clinical Evaluation Report (CER), Technical File. Indian Licensing Documentation. Ability to review, collate and summarize scientific and technical data. Strong knowledge of medical device product development lifecycle is non-negotiable. Project management experience is preferable. Excellent written and verbal communication skills in English.

EXECUTIVE (AHMEDABAD & BANGALORE)
Experience : 1-2 years
Skills : Understands and has working knowledge of Indian regulations (MDR 2017), US FDA Medical Device Regulations, European Medical Device Regulations, and/or other global regulations like Canada, Japan, Australia, Russia and South Korea. Experience in medical device registration support, regulatory assessment of design change execution.