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Deeksha Shrotriya

Recruiter

Gurugram, Haryana, India0 mo experience

Key Highlights

  • 3 years in medical device innovation.
  • Expert in regulatory affairs and quality assurance.
  • Passionate about enhancing patient outcomes.
Stackforce AI infers this person is a Healthcare Regulatory Affairs Specialist focused on medical device compliance and quality management.

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Skills

Other Skills

Complaint HandlingPost Market SurveillanceQuality Assurance & ControlRegulatory AffairsRisk ManagementSoftware Medical Device

About

With 3 years of experience in the medical device industry, I am deeply committed to driving innovation and enhancing patient outcomes through the development, manufacturing, and regulation of cutting-edge healthcare technologies. My career has been dedicated to ensuring that medical devices meet the highest standards of safety, efficacy, and compliance, with a focus on continuous improvement and patient-centered design. I bring expertise in: ✅ Regulatory Affairs: In-depth knowledge of global regulatory requirements (FDA, CE, ISO, etc.) and the ability to navigate complex approval processes efficiently. ✅ Quality Assurance & Control: Proven experience in developing and implementing robust quality management systems (QMS), ensuring product reliability, and meeting industry standards (e.g., ISO 13485, GMP). ✅ Risk Management: Expertise in conducting risk assessments and implementing mitigation strategies to ensure device safety throughout its lifecycle. (e.g., ISO 14971) I am passionate about leveraging technology to create solutions that improve the quality of life for patients. Whether working on product development or navigating complex regulatory landscapes, my goal is always to drive impactful change in healthcare. Let's connect and collaborate to shape the future of medical devices and transform patient care!

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