Swanki Mathur
Regulatory Affairs
- Role
- Regulatory Affairs Manager at Wrig Nanosystems
- Location
- Raipur, CG, IN
- LinkedIn followers
- 500 followers
About Swanki Mathur
Dedicated regulatory affairs professional with 6+ years of experience in the medical device and In vitro diagnostics industry. Specializing in navigating complex regulatory landscapes to ensure compliance with global regulations. Proven track record of successfully bringing innovative medical devices and In vitro devices to market while maintaining the highest standards of quality and safety. Hands-on experience in preparing, submitting, and managing regulatory submissions to health authorities worldwide, including FDA (510(k), EU (CE Mark), India (CDSCO)Skilled in interpreting and implementing regulations, standards, and guidelines such as ISO 13485, MDR, IVDR, and FDA Quality System Regulations (820 CFR). Ensuring compliance throughout the product lifecycle, from development to post-market surveillance.
Experience
Regulatory Affairs Manager
Jul 2020 — Present · Raipur, IN
Education
Xavier Institute of Social Service
Post Graduate
2014 — 2016
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