Rohan Pawar
Regulatory Affairs Specialist | Streamlining Operations, Ensuring Compliance
- Role
- Regulatory Affairs Specialist at Instant Systems Inc
- Location
- Norfolk, VA, US
- LinkedIn followers
- 500 followers
About Rohan Pawar
Regulatory Affairs Specialist | Post Market Surveillance Analyst | Healthcare Analyst…
Experience
Regulatory Affairs Specialist
Aug 2024 — Present · Norfolk, VA, US
Leading 510(k) premarket submissions for Class II medical devices and maintaining compliance with FDA and EU MDR requirements.• Enhancing QMS to meet regulatory standards, supporting risk management assessments, FMEA, and cross-functional compliance efforts.• Collaborating with laboratories for biocompatibility evaluations and performance testing.• Managing product labeling, UDI system implementation, and updating the GUDID database.• Coordinating with FDA, EU Notified Bodies, and Competent Authorities on pre-submission meetings and product development inquiries.• Developing and updating Device Master Record, Design History File, and relevant SOPs and training key personnel to align with industry standards and regulatory updates.
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