Axio Biosolutions Looking for REGULATORY EXECUTIVE at Karnataka Full Time

Designation regulatory executive
Location bangalore
To land this job you will need

Bachelors/ advanced degree in biology, chemistry, or engineering.
Understanding on 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 1-2 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.

For more information, mail to [email protected] or call +91-xxxxxxxxxx

Disclaimer: this job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at anytime at the sole discretion of the employer.

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Posted 5 days ago