Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Timeline
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Nikhil Kalluri

San Francisco,CA

Summary

Quality and Regulatory Affairs expert with over five years of experience in medical devices and digital health. Proficient in program management, data analysis, strategic decision-making, and cross-functional collaboration. Skilled in product development, regulatory compliance, and market analysis through experience at high growth startups. Eager to transition into a Business Development Specialist role to leverage analytical expertise, problem-solving skills, and passion for digital health to drive customer growth and enhance patient outcomes.

Overview

6
6
years of professional experience

Work History

Product Quality and Regulatory Affairs Program Manager

Ceevra
San Francisco, CA
10.2022 - 08.2023
  • Developed and maintained customer accounts for digital health solutions
  • Collaborated with product teams to support the development and implementation of innovative healthcare solutions
  • Conducted research, analysis, and interpretation of healthcare data to generate insights and inform strategic decision-making
  • Engaged in cross-functional collaboration to ensure alignment with strategic objectives
  • Stayed updated on industry trends, regulations, and best practices in digital health and Value-Based Care.

Product Operations Manager, Digital Pathology

PathAI
Boston, MA
11.2021 - 07.2022
  • Managed project timelines and deliverables, ensuring alignment with business objectives and client expectations
  • Developed strategic recommendations based on comprehensive data analyses and market research
  • Coordinated cross-functional teams to drive project success and client satisfaction
  • Created and reviewed KPI dashboards to monitor product performance and identify areas for improvement
  • Engaged with clients and stakeholders to understand their needs and develop tailored solutions.

Quality Engineer II, Product Life Cycle

Visby Medical
San Jose, CA
09.2020 - 11.2021
  • Executed product validation and verification plans, ensuring adherence to regulatory requirements
  • Developed and implemented risk management strategies to mitigate potential product issues
  • Collaborated with engineering teams to enhance product design and functionality
  • Provided analytical support for strategic decision-making processes
  • Assisted in developing customer engagement strategies and improving user experience.

Quality Assurance Analyst

Cepheid
Sunnyvale, CA
01.2020 - 09.2020
  • Developed and maintained a customer complaint dashboard for post-market surveillance
  • Conducted data analyses to identify trends and recommend corrective actions
  • Led pilot projects to improve manufacturing processes and reduce product defects
  • Participated in continuous improvement initiatives to enhance overall product quality
  • Engaged with cross-functional teams to ensure alignment with business goals.

Rotational Program, Quality, Regulatory & Clinical Affairs

Cepheid
Sunnyvale, CA
07.2018 - 01.2020
  • Gained comprehensive experience across quality assurance, regulatory affairs, and clinical operations
  • Developed dashboards to communicate trends and support strategic decision-making
  • Conducted data analyses to support regulatory submissions and compliance activities
  • Collaborated with cross-functional teams to drive project success and regulatory compliance.

Product Marketing Intern

Bruin Biometrics LLC
Los Angeles, CA
12.2017 - 06.2018
  • Created promotional content and conducted market research to support product launches
  • Synthesized competitive intelligence to develop strategic recommendations for go-to-market strategies
  • Assisted in developing business strategies and marketing plans
  • Engaged with stakeholders to understand market needs and drive product development.

R&D Engineering Intern

Bruin Biometrics LLC
Los Angeles, CA
02.2017 - 09.2017
  • Performed bench-top testing to support design verification and validation
  • Documented design requirements and specifications for FDA compliance
  • Collaborated with engineering teams to improve product design and performance.

Education

Masters in Business Administration (MBA) Candidate -

University of California, Berkeley - Haas School of Business
01.2026

Master of Science in Biomedical Engineering -

University of Southern California
01.2018

Bachelor of Science in Bioengineering -

University of California, Los Angeles
01.2016

Skills

  • Project Management
  • Data Analysis
  • Quality Assurance
  • Regulatory Compliance
  • Process Improvement
  • Market research, forecasting, and analysis

Accomplishments

Full Circle - Innovation Design Challenge, Haas School of Business

  • Developed a digital platform and physical community space solution to foster genuine connections and support among young adults.
  • Conducted extensive research and analysis of user needs and industry trends.
  • Collaborated with a team to create wireframes and visual diagrams to communicate product concepts effectively.

Timeline

Product Quality and Regulatory Affairs Program Manager

Ceevra
10.2022 - 08.2023

Product Operations Manager, Digital Pathology

PathAI
11.2021 - 07.2022

Quality Engineer II, Product Life Cycle

Visby Medical
09.2020 - 11.2021

Quality Assurance Analyst

Cepheid
01.2020 - 09.2020

Rotational Program, Quality, Regulatory & Clinical Affairs

Cepheid
07.2018 - 01.2020

Product Marketing Intern

Bruin Biometrics LLC
12.2017 - 06.2018

R&D Engineering Intern

Bruin Biometrics LLC
02.2017 - 09.2017

Masters in Business Administration (MBA) Candidate -

University of California, Berkeley - Haas School of Business

Master of Science in Biomedical Engineering -

University of Southern California

Bachelor of Science in Bioengineering -

University of California, Los Angeles
Nikhil Kalluri