RUPANSHI NAIK
Woodstock,GA
Summary
Regulatory Affairs and Quality Assurance Specialist with expertise in FDA, ISO, and EU compliance, driving global submissions and medical device approvals, seeking new opportunities to contribute to innovative medical technologies.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Engineer and Regulatory Specialist
Plasma Surgical Inc.
10.2021 - Current
- Prepared 510(k) submissions for Class II devices, and developed EU technical documentation to support CE marking under MDD 93/42/EEC and MDR 2017/745, ensuring compliance with ISO 10993 (biocompatibility), ISO 14971 (risk management), and IEC 62304 (software lifecycle processes).
- Contributed to the Quality Management System and served as the lead representative during ISO 13485, FDA, and EU MDD/MDR audits, maintaining ongoing compliance with global regulatory standards.
- Supported new product development by providing regulatory input during design reviews and risk assessments, ensuring alignment with ISO 13485 and 21 CFR Part 820 design control requirements.
- Reviewed and approved Engineering Change Orders (ECOs) to ensure compliance with internal procedures and external regulatory requirements.
- Collaborated with labeling and marketing teams to review advertising, promotional, and product labeling materials for compliance with the FDA, MDR, and other global regulations.
- Led quality projects, including complaint analysis, root cause investigations, and implementation of strategies supporting regulatory requirements and continuous improvement initiatives.
Regulatory and Quality Assurance Specialist
Novo Surgical Inc.
10.2018 - 10.2021
- Maintained QMS and regulatory documents per FDA 21 CFR 820, ISO 13485:2016, and ISO 14971, managing product registrations, recalls, investigations, and UDI labeling for 10,000+ products.
- Developed filing strategies for domestic and international submissions, supporting market expansion into Canada and Saudi Arabia.
- Led internal audits, annual management reviews, and represented the company in ISO 13485:2016 and FDA audits.
- Collaborated with suppliers and customers on regulatory requirements and opportunities.
Regulatory Affairs Specialist
doDOC Corp.
09.2017 - 04.2018
- Created content templates and registration packages for 510(k), PMA, and IDE applications, including walkthrough guides and use cases.
- Experience of working on a Research Paper-White paper titled, 'Large Pharmaceutical Companies: the value of publications in the path to approval.'
Education
Master of Science - Regulatory Affairs for Drug, Biologics and Medical Devices
Northeastern University
Boston, MA06.2018
Bachelor's - pharmacy
Nirma University
Ahmedabad, India, India06.2016
Skills
- Regulatory knowledge and compliance (FDA, EU MDR, ISO 13485)
- Regulatory strategy and project management
- Risk management (ISO 14971) and biocompatibility (ISO 10993)
- Design controls and engineering change orders (ECO)
- Post-market surveillance and audit/inspection readiness
- Cross-functional collaboration and leadership
- Complaint handling and CAPA implementation
- Problem-solving and critical thinking
- Strong communication and negotiation skills
- Detail-oriented and excellent organizational skills
- Time management and ability to work independently
Certification
•RAPS Regulatory Affairs Certification (RAC-Devices) -Granted September 2020
• Exemplar Global Certified MDSAP /ISO 13485 Internal Auditor Training- Granted March 2020
• Received certification training on EU MDR 2017/745 and ISO 14971:2019.
Research and projects
- Roger Sciences, Boston, MA (04/01/18 – 07/01/18)
Project Associate-Regulatory: Addressed FDA Pre-Submission packages, IDEs, Orphan Drug Applications, and 510(k)/De-Novo 510(k) applications. Prepared SOPs and regulatory documents, and delivered strategies for new device approvals. Collaborated with Clinical Research Director on clinical trial protocols and Informed Consent Forms (ICFs). - One Million Acts of Innovation, Ontario, Canada (05/01/17 – 07/01/17)
Regulatory Affairs Specialist: Conducted market research for SaaS targeting retail chain pharmacies through Northeastern University’s Experiential Network, while completing graduate coursework in MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices. - Nirma University, Ahmedabad, India (08/01/15 – 07/01/16)
Regulatory Guidelines for Product Development: Gained expertise in designing quality products and manufacturing processes to ensure intended product performance, supporting the establishment of design space, specifications, and manufacturing controls for safe and efficacious drug products.
Timeline
Quality Engineer and Regulatory Specialist
Plasma Surgical Inc.
10.2021 - Current
Regulatory and Quality Assurance Specialist
Novo Surgical Inc.
10.2018 - 10.2021
Regulatory Affairs Specialist
doDOC Corp.
09.2017 - 04.2018
Master of Science - Regulatory Affairs for Drug, Biologics and Medical Devices
Northeastern University
Bachelor's - pharmacy
Nirma University
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