Raja A
Regulatory Affairs Specialist | IVD & Medical Devices | IVDR, 510(k), CE Marking | Global Submissions | Change Management & Compliance
- Role
- Regulatory Affairs Specialist -ii at QuidelOrtho
- Location
- Columbus, OH, US
- LinkedIn followers
- 500 followers
About Raja A
Regulatory Affairs Specialist with 3+ years of experience supporting global submissions and compliance activities for high-volume IVD and medical device product lines. Skilled in 510(k) preparation, IVDR technical documentation (Class B/C), CE marking, global re-registrations (APAC, EMEA, LATAM), and change-control management.Proven track record of coordinating cross-functional teams, managing regulatory deliverables, and ensuring timely market access. Experienced with risk-impact assessments, labeling/UDI updates, global renewals, and regulatory intelligence across multiple regions.Passionate about helping innovative diagnostic products reach global markets faster, while maintaining patient safety, quality, and compliance.Specialties:IVD, IVDR, CE Marking, 510(k), Global Submissions, Health Canada MDL, APAC/EMEA/ LATAM- Registrations, Change Control, Labeling, UDI, Technical Documentation, SOP Development, Regulatory Strategy, SAP
Experience
Regulatory Affairs Specialist -ii
Dec 2022 — Present · OH, US
Supported 80+ global submissions across APAC, EMEA, LATAM, and North America, maintaining continuous market access.• Prepared and reviewed IVDR Technical Documentation for Class B/C IVDs, ensuring NB submission readiness.• Coordinated 510(k) preparatory activities and regulatory justifications for design/labeling updates.• Led global re-branding and change-control activities across 30+ labeling and IFU files.• Managed renewals, FSC/CFG requests, and country registrations for APAC, Middle East, and LATAM regions.• Collaborated with cross-functional teams (QA, R&D, Packaging, Labeling) to align on compliance and risk assessments.• Ensured regulatory integrity across MasterControl, ServiceNow, and Windchill documentation workflows.
Education
GITAM Deemed University
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
2016 — 2020
St. Cloud State University
Master's degree, regulatory affairs ( devices )
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