layiq
/la·yiq/adjective
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
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Job opportunity
Senior Regulatory Affairs Specialist
Dozee
Bangalore
Source: Dozee careers · View original posting
Employer job description
From Dozee's posting. “We” and “our” refer to the employer.
Overview:
Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company.
We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you’ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models.
Responsibilities :
- Evaluate medical device and SaMD regulations and develop global regulatory strategies to bring products to market.
- Review and approve design control documentation, risk management files, and product labeling in accordance with FDA, EU MDR, and other international regulations Author and manage FDA submissions, including:
- ○ Q-Submission (Q-Sub) requests
- ○ Traditional and Special 510(k) submissions
- ○ Regulatory filings for Software as a Medical Device (SaMD)