Shailesh P.
Medical Device Regulatory Affairs
- Role
- Regulatory and Quality Specialist at Vycor Medical, Inc
- Location
- Boca Raton, FL, US
- LinkedIn followers
- 500 followers
About Shailesh P.
Regulatory and Quality Affairs Professional with a strong background in medical devices…
Experience
Regulatory and Quality Specialist
Jun 2024 — Present · Boca Raton, FL, US
Acting as Management Representative, FDA correspondent, and PRRC (Person Responsible for Regulatory Compliance) for Vycor Medical.• Ensuring compliance with FDA, CE Mark, ISO, and MDSAP requirements and ensuring adherence to evolving global regulatory frameworks.• Performing product registration and annual renewals to comply with Global Regulations ensuring smooth business around the globe with the help of international authorized representatives.• Responsible for maintaining and creating all regulatory documentation and records, including device databases (GUDID, EUDAMED, etc.).• Handling day-to-day QA/RA matters such as customer complaints, CAPAs etc, product incoming inspections, and maintenance of records. Handling internal and external audits together with the CFO.• Continually reviewing, authoring, and refining the Quality Management System (QMS), Standard Operating Procedures (SOPs), and related documentation, and ensuring their consistent application across the organization• Conducting and documenting Management Reviews and other required regular updates/reviews. Managing annual key supplier assessments. Coordinating post-market surveillance activities.• Responsible for ensuring staff training in regulatory matters is kept up to date.• Maintaining Design History File (DHF), Device Master Record (DMR), and Device History Records (DHR)• Managing Documentation control, Risk analyses, and Technical Files.• Collaborating with Product Development to define and document testing and inspection requirements aligned with regulatory expectations.
Education
Northeastern University
Master of Science - MS, Regulatory Affairs
Narsee Monjee Institute of Management Studies
Masters of pharmacy, Drug Development and Regulatory Sciences
University of Mumbai
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Changu Kana Thakur Institute Of Management Studies And Research
11-12th grade, Science
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