Assistant Manager Quality and Regulatory

Job Summary

Position - Assistant Manager Quality and Regulatory

Location - Turbhe, Navi Mumbai

Education Qualification - MSc, B. Tech, M. Tech, B. Eng

Responsibilities

• Execute required activities as part of ISO 13485, 15189, 27001 and ISO 62304 compliance
• Create, revise, and maintain relevant policies and procedures.
• Provide support for internal and external compliance audits.
• Perform periodic assessments and risk evaluations.
• Undertake activities relating to regulatory submissions for software as a medical device

Requirements

• The candidate must have the ability to execute tasks and document information independently.
• Have an understanding of medical devices, quality assurance and quality checks
• Awareness of ISO 13485, 15189, 27001 and ISO 62304.
• Internal auditor certification for ISO 13485, 15189, 27001 or ISO 62304 is preferable.
• An understanding of regulatory pathways is preferable.

Skills

• Keen attention to details.
• Ability to critically evaluate scientific literature and integrate information from multiple sources..
• Ability to work independently with minimal supervision as well as collaboratively in a team environment.
• Excellent organizational and time management skills with the ability to prioritize tasks effectively
• Strong interpersonal and communication skills with the ability to interact professionally with diverse stakeholders

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.