Senior Regulatory Executive

Axio Biosolutions

Bangalore, IN
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 06/03/2021
  • Website: www.axiobio.com
  • Company Address: #541, 5th main, 16th cross, Indiranagar 2nd stage, Bangalore - 560038, Karnataka, India

About Axio Biosolutions

Axio was founded in 2008 by Leo Mavely, a bioengineer to develop novel biopolymer platform based products for wound care. Axio has the distinction to be the first company from India to design, develop and commercialize an Emergency Haemostat for Trauma care. Vision of Axio is to develop affordable, high impact medical products that can solve unmet healthcare needs of emerging markets. Controlling life-threatening bleeding continues to be the major cause of death from traumatic injuries.

Job Description

Designation Senior Regulatory Executive
Location Bangalore
 
 
To land this job you will need
Bachelors/ Advanced degree in Biology, Chemistry, or Engineering.
Understanding of Indian Medical device rules, US FDA regulations, European medical device regulations, and/or other global regulations.
Experience working on EU MDR & MDD, ISO 13485, ISO 14971, PMS, CER & DHF.
Excellent Communication, Detail Oriented, and Critical Thinker.
 
 
Primary Job Function
To ensure adherence to regulation and compliance of the company as per global regulatory requirements.
 
Experience Required Minimum of 2-3 years
 
 
Core Responsibilities
Prepare regulatory strategies and ensure audit preparation for all the quality & regulatory audits.
Evaluate, update, and collaborate on applicable regulatory affairs policies, procedures, and training to ensure they reflect current regulatory requirements as
required.
Work with the International Sales team for product registration requirements.
Preparation of regulatory dossiers for various countries and maintain documents like PMS, CER &DHFs.
Develop and deliver regulatory training and awareness programs to ensure compliance with internal/external regulations.
Continually improve knowledge of current regulatory compliance guidelines and safety requirements.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.