Ronit Shah
- Role
- Regulatory Affairs Specialist at AtriCure, Inc.
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Ronit Shah
Dedicated and dependable Regulatory Affairs Specialist with extensive expertise in the…
Experience
Regulatory Affairs Specialist
May 2021 — Present
Prepared EU MDR/MDD Technical Documentation to secure/maintain marketing approvals for products (Class I, II & to treat global Afib (Atrial Fibrillation) epidemic and healing the lives of patient. • Drafted global submissions to secure/maintain marketing approvals. Interface directly Regulatory Authorities during review cycles or pre-planning sessions. • Reviewed product and manufacturing changes for compliance with applicable regulations and prepared global regulatory assessment. • Regulatory liaison with global Regulatory Authorities on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity. • Review of protocols and reports to support regulatory submissions as needed. • Improved multiple regulatory process’ to make it more efficient and less time consuming. For example updates to ChRP(Change Control) report/tracker. • Took initiative and updated the Australian EPC/DOC updates for the MDSAP audit. • Volunteered and provided back room support for the MDSAP Audit 2021. • Updated the Regulatory procedures to reflect the latest guidances from notified bodies and health authorities.
Skills
- Project Planning
- Customer Relationship Management (Crm)
- Quality Assurance
- Production Planning
- Mechanical Engineering
- Analytical Skills
- Microsoft Powerpoint
- Shipping & Receiving
- Program Management
- Management
- Project Management
- Erp
- Customer Service
- Microsoft Office
- Marketing
- Research
- Quality Control
- Team Management
- Teamwork
- Procurement
- Powerpoint
- Autocad
- Leadership
- Microsoft Excel
- Risk Management
- Engineering
- Mrp
- Public Speaking
- Social Media
- Microsoft Word
- Static Analysis
- Supply Chain Management
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