Priyanka Dheer

About Priyanka Dheer

I am a Graduate Research Assistant at Chapman School of Pharmacy, where I oversee all submissions and grade assessments on the Canvas learning management system, preparing course materials, leading discussions, and offering academic support to students. I facilitate a positive learning environment, bridging the gap between students and faculty. I am also pursuing an MS in Pharmaceutical Sciences, driven by a passion for Regulatory Affairs and Social Administrative Sciences.With three years of hands-on experience in the Medical Device Regulatory Affairs department at Virchow Biotech Pvt Ltd, I have contributed to the development of innovative medical products, such as COPD diagnostic tools and hydrogel wound dressings. I have drafted quality manual contributions and prepared the medical device file aiming for ISO 13485 certification. I have also supported device compliance by updating user manuals and labeling to align with current regulatory standards, and managed 510(k) cover letter preparation. I am a certified GCP for Clinical Investigations of Devices by CITI Program, and I have gained a comprehensive education on the entire research process through BioLim Centre for Science & Technology. I have a strong interdisciplinary perspective, exploring healthcare, policy, and patient outcomes, and I stay updated with evolving regulations. I am eager to connect with mentors, fellow students, and industry professionals for learning, collaboration, and growth in the dynamic field of Regulatory Affairs.

Experience

1. Regulatory Affairs Specialist

   Hamilton Company

   Jan 2025 — Present · Reno, NV, US

   Ensured end-to-end regulatory compliance for FDA, IVDR, KC Mark, EU REACH and RoHS regulations, as well as material compliance requirements for laboratory and robotic products- Prepared and submitted regulatory documentation, conducted gap analyses against updated standards and GxPs, and collaborated with cross-functional teams to address technical documentation requirements in support of IVDR conformity- Created and maintained technical files substantiating product conformity, assessed regulatory requirements, and submitted Declarations of Conformity (DoC) based on NTRL test reports- Reviewed and evaluated product labelling to ensure accuracy, regulatory alignment, and readiness for regulatory audits- Monitored evolving regulatory requirements across multiple jurisdictions and contributed to compliance strategies that facilitated market access for laboratory and robotic products- Conducted Post-Market Surveillance (PMS) activities across all product lines, including data collection, trend analysis, incident monitoring, and reporting to support ongoing safety, performance, and regulatory compliance- Conducted in-process inspections and actively participated in internal audits, identifying non-conformances, supporting root cause analysis, and driving corrective and preventive actions (CAPAs) to maintain quality system integrity- Proactively monitored and assessed emerging regulatory requirements across global markets, evaluating their impact on existing products and processes, and implementing timely updates to ensure continued compliance and uninterrupted market access.

Education

• Chapman University School of Pharmacy

  Master's degree, Pharmaceutical Sciences

• Kalinga Institute of Industrial Technology, Bhubaneswar

  B.Tech/M.Tech (Dual Degree) in Biotechnology, Biotechnology